The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Tri-service Omv Vaporizer.
| Device ID | K864589 |
| 510k Number | K864589 |
| Device Name: | TRI-SERVICE OMV VAPORIZER |
| Classification | Gas-machine, Anesthesia |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Ray Pizinger |
| Correspondent | Ray Pizinger BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-21 |
| Decision Date | 1987-06-05 |