Regulatory Documents & Certifications for the USA

Certificate No. 11863-8-2024-1

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Part Number 1

Revision 1

Document Type 1

Filename 1723750014872-CFG-11863-8-2024_ABPM.pdf

Certificate to Foreign Government

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Part Number 1

Revision 1

Document Type 1

Download Language English

Filename 2022_CFG_CT40.pdf

Certificate to Foreign Government

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Part Number 1

Revision 1

Document Type 1

Download Language English

Filename 2022_CFG_Disposable_Cuffs.pdf

Certificate to Foreign Government

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Part Number 1

Revision 1

Document Type 1

Download Language English

Filename 2022_CFG_APC_OPD_Durable.pdf

Certificate No. 1205-10-2024-1

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Part Number 1

Revision 1

Document Type 1

Filename 1730715158961-CFG-1205-10-2024_Tango.pdf

Certificate to Foreign Government

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Part Number 1

Revision 1

Document Type 1

Download Language English

Filename CFG_V2020-265_Vet.pdf

FDA SE Letter for the SunTech CT40

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Part Number 1

Revision 1

Document Type 1

Download Language English

Filename K160439.Letter.SE.Final_Corrected_20170217.pdf

SE Letter for the All Purpose and One Piece Durable Cuffs

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Part Number 1

Revision 1

Document Type 1

Filename 510(k)_se_letter,_apc.pdf

SE Letter for the SunTech Disposable and Vinyl Cuffs

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Part Number 1

Revision 1

Document Type 1

Filename k080854_se_letter.pdf

SE Letter for the Oscar 2 ABPM

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Part Number 1

Revision 1

Document Type 1

Download Language English

Filename K151520.Letter.SE.pdf

SE Letter for the SunTech Oscar 2 ABPM system.

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Part Number 1

Revision 1

Document Type 1

Filename oscar2,_se_letter.pdf

SE Letter for the SunTech 247

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Part Number 1

Revision 1

Document Type 1

Filename se_letter,_halo.pdf

510k Information for the Tango M2 by SunTech Medical

Information

Part Number 1

Revision 1

Document Type 1

Download Language English

Filename se_letter_tangom2.pdf

Certificate to Foreign Government - ABPM

Certificate to Foreign Government - CT40 HOT

Certificate to Foreign Government - Disposable Cuff HOT

Certificate to Foreign Government - Durable Cuffs HOT

Certificate to Foreign Government - Tango

Certificate to Foreign Government - Vet HOT

FDA SE Letter for the SunTech CT40 HOT

SE Letter for the APC and OPD Cuffs HOT

SE Letter for the Disposable and Vinyl Cuffs HOT

SE Letter for the Oscar 2 (Model 250) ABPM HOT

SE Letter for the Oscar 2 ABPM HOT

SE Letter for the SunTech 247 HOT

Tango M2 510(k) SE Letter HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf0"/> Certificate to Foreign Government - ABPM

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf1"/> Certificate to Foreign Government - CT40 HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf2"/> Certificate to Foreign Government - Disposable Cuff HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf3"/> Certificate to Foreign Government - Durable Cuffs HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/pdf.png" style="text-align:top;border:0px;" width="32" height="32" alt="pdf4"/> Certificate to Foreign Government - Tango

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf5"/> Certificate to Foreign Government - Vet HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf6"/> FDA SE Letter for the SunTech CT40 HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf7"/> SE Letter for the APC and OPD Cuffs HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf8"/> SE Letter for the Disposable and Vinyl Cuffs HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf9"/> SE Letter for the Oscar 2 (Model 250) ABPM HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf10"/> SE Letter for the Oscar 2 ABPM HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf11"/> SE Letter for the SunTech 247 HOT

<img src="https://www.suntechmed.com/images/jdownloads/fileimages/flat_1/finefiles_pdf.gif" style="text-align:top;border:0px;" width="32" height="32" alt="finefiles_pdf12"/> Tango M2 510(k) SE Letter HOT

Certificate to Foreign Government - ABPM

Certificate to Foreign Government - CT40 HOT

Certificate to Foreign Government - Disposable Cuff HOT

Certificate to Foreign Government - Durable Cuffs HOT

Certificate to Foreign Government - Tango

Certificate to Foreign Government - Vet HOT

FDA SE Letter for the SunTech CT40 HOT

SE Letter for the APC and OPD Cuffs HOT

SE Letter for the Disposable and Vinyl Cuffs HOT

SE Letter for the Oscar 2 (Model 250) ABPM HOT

SE Letter for the Oscar 2 ABPM HOT

SE Letter for the SunTech 247 HOT

Tango M2 510(k) SE Letter HOT