K-number	K211526
Device name	Portable Scalp Cooling System
Applicant	Cooler Heads Care, Inc.
Product code	PMC
Device class	Class II
Decision date	Oct 21, 2021
Decision	Substantially Equivalent
Regulation	878.4360

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Source

View the full FDA submission: accessdata.fda.gov

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Portable Scalp Cooling System

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