Portable Scalp Cooling System— 510(k) K211526

Name: FDA 510(k) clearance K211526
Creator: U.S. Food and Drug Administration
Published: 2021-10-21

Substantially Equivalent

Cooler Heads Care, Inc.

FDA 510(k) clearance K211526 for Portable Scalp Cooling System, Substantially Equivalent on 2021-10-21. Applicant: Cooler Heads Care, Inc.. Device class: 2.

Clearance details

Applicant: Cooler Heads Care, Inc.
Product code: Code PMC
Device class: Class 2
Regulation: 21 CFR 878.4360
Advisory panel: General, Plastic Surgery
Date received: 2021-05-17
Decision date: 2021-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.