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510(k) K112728

HEPAIRX VENTILATING AIR PURIFIER by Air Innovations, Inc. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2013
Date Received
September 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

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