FDA 510(k) Application Details - K223328

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K223328
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	AeroClean Technologies, Inc. 10455 Riverside Drive, Ste. 100 Palm Beach Gardens, FL 33410 US Other 510(k) Applications for this Company
Contact	Richard 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	10/31/2022
Decision Date	11/30/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review