The following data is part of a premarket notification filed by Air Innovations, Inc. with the FDA for Hepairx Ventilating Air Purifier.
| Device ID | K112728 |
| 510k Number | K112728 |
| Device Name: | HEPAIRX VENTILATING AIR PURIFIER |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | AIR INNOVATIONS, INC. 7000 PERFORANCE DRIVE North Syracuse, NY 13212 |
| Contact | Lawrence Wetzel |
| Correspondent | Lawrence Wetzel AIR INNOVATIONS, INC. 7000 PERFORANCE DRIVE North Syracuse, NY 13212 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-20 |
| Decision Date | 2013-01-23 |