The following data is part of a premarket notification filed by Medicor Usa Ltd. with the FDA for Model Bion 2/type 90 Room Ionizer.
| Device ID | K851358 |
| 510k Number | K851358 |
| Device Name: | MODEL BION 2/TYPE 90 ROOM IONIZER |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
| Contact | Geza Pataky |
| Correspondent | Geza Pataky MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-07-01 |