Medical Device Manufacturer · US , Morrisville , NC

Suntech Medical, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2005

Recent clearances: Oscar 2, TANGO M2 BLOOD PRESSURE MONITOR, ALL PURPOSE CUFF, MODEL 222APC

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Suntech Medical, Inc. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Feb 19, 2016

Cardiovascular · 259d

Cleared Nov 02, 2012

TANGO M2 BLOOD PRESSURE MONITOR

Cardiovascular · 87d

Cleared Oct 20, 2008

DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100

Cardiovascular · 207d

Cleared May 02, 2007

Cardiovascular · 44d

Cleared Jun 07, 2006

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060

Cardiovascular · 72d

Cleared Jan 05, 2006

TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM

Cardiovascular · 50d

Cleared Sep 09, 2005

ALL PURPOSE CUFF, MODEL 222APC

Cardiovascular · 58d