truFreeze System
K-Number: K162695 · 2016-10-25
ApplicantCSA Medical, Inc.
Decision Date2016-10-25
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
truFreeze System is a medical device manufactured by CSA Medical, Inc.. It received FDA 510(k) clearance on 2016-10-25 under approval number K162695. 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 truFreeze System?
truFreeze System is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by CSA Medical, Inc.. The 510(k) number is K162695.
When was truFreeze System approved by the FDA?
truFreeze System received FDA 510(k) clearance on 2016-10-25, under approval number K162695.
What company makes truFreeze System?
truFreeze System is manufactured by CSA Medical, Inc..
What is the FDA product code for truFreeze System?
The FDA product code for truFreeze System is GEH.
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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.