Medical Device Manufacturer · US , San Diego , CA

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

9 submissions · 9 cleared · Since 2012

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.

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