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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K223328
Device Name Purgo
Applicant
Aeroclean Technologies, Inc.
10455 Riverside Dr., Suite 100
Palm Beach Gardens,  FL  33410
Applicant Contact Richard Foster
Correspondent
MethodSense, Inc.
1 Copley Pkwy.,
Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number880.6500
Classification Product Code
FRA  
Date Received10/31/2022
Decision Date 11/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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