Dermal Cooling System
K-Number: K213294 · 2022-11-10
ApplicantR2 Technologies, Inc.
Decision Date2022-11-10
Product CodeQPZ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dermal Cooling System is a medical device manufactured by R2 Technologies, Inc.. It received FDA 510(k) clearance on 2022-11-10 under approval number K213294. The device is classified under product code QPZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dermal Cooling System?
Dermal Cooling System is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by R2 Technologies, Inc.. The 510(k) number is K213294.
When was Dermal Cooling System approved by the FDA?
Dermal Cooling System received FDA 510(k) clearance on 2022-11-10, under approval number K213294.
What company makes Dermal Cooling System?
Dermal Cooling System is manufactured by R2 Technologies, Inc..
What is the FDA product code for Dermal Cooling System?
The FDA product code for Dermal Cooling System is QPZ.
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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.