truFreeze Rapid AV Spray Kit
K-Number: K171522 · 2017-07-14
ApplicantCSA Medical, Inc.
Decision Date2017-07-14
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
truFreeze Rapid AV Spray Kit is a medical device manufactured by CSA Medical, Inc.. It received FDA 510(k) clearance on 2017-07-14 under approval number K171522. 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 Rapid AV Spray Kit?
truFreeze Rapid AV Spray Kit is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by CSA Medical, Inc.. The 510(k) number is K171522.
When was truFreeze Rapid AV Spray Kit approved by the FDA?
truFreeze Rapid AV Spray Kit received FDA 510(k) clearance on 2017-07-14, under approval number K171522.
What company makes truFreeze Rapid AV Spray Kit?
truFreeze Rapid AV Spray Kit is manufactured by CSA Medical, Inc..
What is the FDA product code for truFreeze Rapid AV Spray Kit?
The FDA product code for truFreeze Rapid AV Spray Kit is GEH.
Other Devices by CSA Medical, 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.