Kelvi

FDA Filings

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

FDA Registration(s)
Registration Number3015252349
FEI Number3015252349
NameKelvi
Owner & OperatorHypothermia Devices, Inc. (dba Kelvi)
Contact Address413 N Oak Street
Inglewood CA 90302 US
Official Correspondent
  • Julio L Vergara
  • x-310-9234749-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address413 N Oak Street
Inglewood, CA 90302 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]
Kelvi Shoulder Pro Smart Wrap2018-07-10
Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]
Kelvi Pro Umbilical2018-07-10
Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]
Kelvi Pro Console2018-07-10
Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]
Kelvi Knee Pro Smart Wrap2018-07-10
Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]
Kelvi Hand Station2018-07-10
Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]
Kelvi Back Pro Smart Wrap2018-07-10
Kelvi [Hypothermia Devices, Inc. (dba Kelvi)]
Kelvi Ankle Pro Smart Wrap2018-07-10

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