FDA 510(k) Application Details - K213753

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K213753
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	AeroClean Technologies, LLC 10455 Riverside Drive, Ste. 100 Palm Beach Gardens, FL 33410 US Other 510(k) Applications for this Company
Contact	Riachard Foster Other 510(k) Applications for this Contact
Regulation Number	880.6500   More FDA Info for this Regulation Number
Classification Product Code	FRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2021
Decision Date	06/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review