Medical Device Manufacturer · US , San Diego , CA

Sotera Wireless, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2012
9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Sotera Wireless, Inc. Cardiovascular ✕

9 devices
1-9 of 9
Cleared Jun 19, 2018
ViSi Mobile Monitoring System
K180472 · MHX
Cardiovascular · 117d
Cleared Dec 14, 2015
ViSi Mobile Monitoring System
K152341 · MWI
Cardiovascular · 117d
Cleared Jul 20, 2015
Visi Mobile Monitoring System, Visi Mobile Chest Sensor
K142827 · MHX
Cardiovascular · 293d
Cleared Apr 30, 2015
ViSi Mobile Monitoring System
K150361 · MWI
Cardiovascular · 77d
Cleared Jan 23, 2015
Visi Mobile Monitoring System
K143751 · MWI
Cardiovascular · 23d
Cleared Dec 18, 2013
VISI MOBILE MONITIORING SYSTEM
K133586 · MWI
Cardiovascular · 27d
Cleared Oct 07, 2013
VISI MOBILE MONITORING SYSTEM
K130709 · MWI
Cardiovascular · 206d
Cleared Aug 15, 2012
VISI MOBILE MONITORING SYSTEM
K122036 · MWI
Cardiovascular · 35d
Cleared Mar 22, 2012
VISI MOBILE MONITORING SYSTEM
K112478 · MWI
Cardiovascular · 206d
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