Sotera Wireless, Inc. is one of 18408 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sotera Wireless, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ViSi Mobile Monitoring System, ViSi Mobile Monitoring System, Visi Mobile Monitoring System, Visi Mobile Chest Sensor
9
Total
9
Cleared
0
Denied
Sotera Wireless, Inc. has 9 FDA 510(k) cleared medical devices. Based in San Diego, US.
Historical record: 9 cleared submissions from 2012 to 2018. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Sotera Wireless, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Sotera Wireless, Inc.
9 devices
Cleared
Jun 19, 2018
ViSi Mobile Monitoring System
Cardiovascular
117d
Cleared
Dec 14, 2015
ViSi Mobile Monitoring System
Cardiovascular
117d
Cleared
Jul 20, 2015
Visi Mobile Monitoring System, Visi Mobile Chest Sensor
Cardiovascular
293d
Cleared
Apr 30, 2015
ViSi Mobile Monitoring System
Cardiovascular
77d
Cleared
Jan 23, 2015
Visi Mobile Monitoring System
Cardiovascular
23d
Cleared
Dec 18, 2013
VISI MOBILE MONITIORING SYSTEM
Cardiovascular
27d
Cleared
CT
Oct 07, 2013
VISI MOBILE MONITORING SYSTEM
Cardiovascular
206d
Cleared
Aug 15, 2012
VISI MOBILE MONITORING SYSTEM
Cardiovascular
35d
Cleared
CT
Mar 22, 2012
VISI MOBILE MONITORING SYSTEM
Cardiovascular
206d