The following data is part of a premarket notification filed by Duracraft Corp. with the FDA for Hepa Air Cleaner.
| Device ID | K940573 |
| 510k Number | K940573 |
| Device Name: | HEPA AIR CLEANER |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | DURACRAFT CORP. 355 MAIN ST. Whitinsville, MA 01588 |
| Contact | Arthur Wong |
| Correspondent | Arthur Wong DURACRAFT CORP. 355 MAIN ST. Whitinsville, MA 01588 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-08 |
| Decision Date | 1994-08-25 |