Paxman Scalp Cooler
K-Number: K173032 · 2018-06-07
ApplicantPaxman Coolers Limited
Decision Date2018-06-07
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 2018-06-07 under approval number K173032. 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 2018-06-07. It is manufactured by Paxman Coolers Limited. The 510(k) number is K173032.
When was Paxman Scalp Cooler approved by the FDA?
Paxman Scalp Cooler received FDA 510(k) clearance on 2018-06-07, under approval number K173032.
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.