K-number	K223328
Device name	Purgo
Applicant	Aeroclean Technologies, Inc.
Product code	FRA
Device class	Class II
Decision date	Nov 30, 2022
Decision	Substantially Equivalent
Regulation	880.6500

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Source

View the full FDA submission: accessdata.fda.gov

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Purgo

Everything you need for a 510(k) submission. Nothing you don't.