510(k) K112728
K112728 is an FDA 510(k) premarket notification submitted by Air Innovations, Inc. for the device "HEPAIRX VENTILATING AIR PURIFIER". The FDA issued a decision of Substantially Equivalent on January 23, 2013. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.
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