Sotera Wireless

FDA Filings

This page includes the latest FDA filings for Sotera Wireless. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009673645
FEI Number3009673645
NameSOTERA WIRELESS
Owner & OperatorSotera Wireless, Inc.
Contact Address10020 Huennekens Street
San Diego CA 92121 US
Official Correspondent
  • Frank Pokrop
  • x-858-3734832-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10020 Huennekens St
San Diego, CA 92121 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
SOTERA WIRELESS [Sotera Wireless, Inc.]
ViSi Mobile Monitoring System2019-04-12
SOTERA WIRELESS [Sotera Wireless, Inc.]
ViSi Mobile Monitoring System2019-04-12
SOTERA WIRELESS [Sotera Wireless, Inc.]
ViSi Mobile Monitoring System2019-04-12
SOTERA WIRELESS [Sotera Wireless, Inc.]
ViSi Mobile Monitoring System2019-04-12
SOTERA WIRELESS [Sotera Wireless, Inc.]
ViSi Mobile Monitoring System2019-04-12
SOTERA WIRELESS [Sotera Wireless, Inc.]
ViSi Mobile Monitoring System2019-04-12
SOTERA WIRELESS [Sotera Wireless, Inc.]
Thumb Tape2017-08-16
SOTERA WIRELESS [Sotera Wireless, Inc.]
Visi Mobile InSight2015-12-16
SOTERA WIRELESS [Sotera Wireless, Inc.]
Visi Mobile InSight2015-12-16
SOTERA WIRELESS [Sotera Wireless, Inc.]
Visi Mobile InSight2015-12-16
SOTERA WIRELESS [Sotera Wireless, Inc.]
Visi Mobile InSight2015-12-16
SOTERA WIRELESS [Sotera Wireless, Inc.]
Visi Mobile InSight2015-12-16
SOTERA WIRELESS [Sotera Wireless, Inc.]
Visi Mobile InSight2015-12-16
SOTERA WIRELESS [Sotera Wireless, Inc.]
ViSi Mobile Monitoring System, ViSi Mobile Chest Sensor2015-08-28

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