TANGO M2 BLOOD PRESSURE MONITOR

System, Measurement, Blood-pressure, Non-invasive

SUNTECH MEDICAL, INC.

The following data is part of a premarket notification filed by Suntech Medical, Inc. with the FDA for Tango M2 Blood Pressure Monitor.

Pre-market Notification Details

• Device ID: K122401
• 510k Number: K122401
• Device Name: TANGO M2 BLOOD PRESSURE MONITOR
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC 27560
• Contact: Chuck Setzer
• Correspondent: Chuck Setzer; SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC 27560
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-07
• Decision Date: 2012-11-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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