The following data is part of a premarket notification filed by Hmi Industries, Inc. with the FDA for Defender Room Air Cleaner, Model Rac-4000a.
| Device ID | K010616 |
| 510k Number | K010616 |
| Device Name: | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | HMI INDUSTRIES, INC. 13325 DARICE PKWY. Strongville, OH 44149 |
| Contact | Jacqueline Percell |
| Correspondent | Jacqueline Percell HMI INDUSTRIES, INC. 13325 DARICE PKWY. Strongville, OH 44149 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-01 |
| Decision Date | 2001-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863342000318 | K010616 | 000 |