Paxman Scalp Cooler
K-Number: K163484 · 2017-04-17
ApplicantPaxman Coolers Limited
Decision Date2017-04-17
Product CodePMC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Paxman Scalp Cooler is a medical device manufactured by Paxman Coolers Limited. It received FDA 510(k) clearance on 2017-04-17 under approval number K163484. The device is classified under product code PMC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Paxman Scalp Cooler?
Paxman Scalp Cooler is a medical device that received FDA 510(k) clearance on 2017-04-17. It is manufactured by Paxman Coolers Limited. The 510(k) number is K163484.
When was Paxman Scalp Cooler approved by the FDA?
Paxman Scalp Cooler received FDA 510(k) clearance on 2017-04-17, under approval number K163484.
What company makes Paxman Scalp Cooler?
Paxman Scalp Cooler is manufactured by Paxman Coolers Limited.
What is the FDA product code for Paxman Scalp Cooler?
The FDA product code for Paxman Scalp Cooler is PMC.
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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.