TargetCool
K-Number: K230599 · 2023-06-22
ApplicantRecensmedical, Inc.
Decision Date2023-06-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
TargetCool is a medical device manufactured by Recensmedical, Inc.. It received FDA 510(k) clearance on 2023-06-22 under approval number K230599. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TargetCool?
TargetCool is a medical device that received FDA 510(k) clearance on 2023-06-22. It is manufactured by Recensmedical, Inc.. The 510(k) number is K230599.
When was TargetCool approved by the FDA?
TargetCool received FDA 510(k) clearance on 2023-06-22, under approval number K230599.
What company makes TargetCool?
TargetCool is manufactured by Recensmedical, Inc..
What is the FDA product code for TargetCool?
The FDA product code for TargetCool is GEH.
Other Devices by Recensmedical, Inc.
Related Devices (Code: GEH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.