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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 K201220
Device Name Aerus Medical Guardian,model F170A
Applicant
Aerus Medical, LLC
14841 Dallas Pkwy.,
Suite 500, The Aberdeen Bldg.
Dallas,  TX  75254
Applicant Contact Andrew Eide
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number880.6500
Classification Product Code
FRA  
Date Received05/06/2020
Decision Date 06/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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