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FDA 510(k)

Portable Scalp Cooling System

K-Number: K211526 · 2021-10-21

ApplicantCooler Heads Care, Inc.
Decision Date2021-10-21
Product CodePMC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Portable Scalp Cooling System is the device name listed in this FDA 510(k) record. The listed applicant is Cooler Heads Care, Inc.. It received FDA 510(k) clearance on 2021-10-21 under 510(k) number K211526. 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 Portable Scalp Cooling System?

Portable Scalp Cooling System is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Cooler Heads Care, Inc.. The 510(k) number is K211526.

When did Portable Scalp Cooling System receive FDA 510(k) clearance?

Portable Scalp Cooling System received FDA 510(k) clearance on 2021-10-21, under 510(k) number K211526.

Who is the listed applicant for Portable Scalp Cooling System?

The FDA 510(k) record lists Cooler Heads Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Scalp Cooling System?

The FDA product code for Portable Scalp Cooling System is PMC.

Related Clinical Trials

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.

NCT06215469Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)ACTIVE_NOT_RECRUITING

Related Devices (Code: PMC)

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.

K252289Eva Scalp Cooling SystemStemtech Medical Devices Private LimitedK191166DigniCap DeltaDignitana, Inc.K173032Paxman Scalp CoolerPaxman Coolers LimitedK170871DigniCap Scalp Cooling SystemDignitana ABK163484Paxman Scalp CoolerPaxman Coolers Limited

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.

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