The following data is part of a premarket notification filed by Healthway Products, Inc. with the FDA for Advanced Air Purification System; Hepa Air Cleaning System.
| Device ID | K012549 |
| 510k Number | K012549 |
| Device Name: | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | HEALTHWAY PRODUCTS, INC. PO BOX 2729 Syracuse, NY 13220 -2729 |
| Contact | Dick Briggs |
| Correspondent | Dick Briggs HEALTHWAY PRODUCTS, INC. PO BOX 2729 Syracuse, NY 13220 -2729 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2002-02-04 |