FDA 510(k)

Paxman Scalp Cooler

K-Number: K173032 · 2018-06-07

Decision Date2018-06-07

Product CodePMC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Paxman Scalp Cooler is the device name listed in this FDA 510(k) record. The listed applicant is Paxman Coolers Limited. It received FDA 510(k) clearance on 2018-06-07 under 510(k) 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. The listed applicant is Paxman Coolers Limited. The 510(k) number is K173032.

When did Paxman Scalp Cooler receive FDA 510(k) clearance?

Paxman Scalp Cooler received FDA 510(k) clearance on 2018-06-07, under 510(k) number K173032.

Who is the listed applicant for Paxman Scalp Cooler?

The FDA 510(k) record lists Paxman Coolers Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paxman Scalp Cooler?

The FDA product code for Paxman Scalp Cooler is PMC.

Other records listing Paxman Coolers Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163484Paxman Scalp Cooler

Related Devices (Code: PMC)

K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited K211526Portable Scalp Cooling SystemCooler Heads Care, Inc.K191166DigniCap DeltaDignitana, Inc.K170871DigniCap Scalp Cooling SystemDignitana AB K163484Paxman Scalp CoolerPaxman Coolers Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.