HEPAIRX VENTILATING AIR PURIFIER— 510(k) K112728

Name: FDA 510(k) clearance K112728
Creator: U.S. Food and Drug Administration
Published: 2013-01-23

Substantially Equivalent

Air Innovations, Inc.

FDA 510(k) clearance K112728 for HEPAIRX VENTILATING AIR PURIFIER, Substantially Equivalent on 2013-01-23. Applicant: Air Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Air Innovations, Inc.
Product code: Code FRF
Device class: Class 2
Regulation: 21 CFR 880.5045
Advisory panel: General Hospital
Date received: 2011-09-20
Decision date: 2013-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Syracuse, NY, US

Download summary PDF View on FDA.gov ↗

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