The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear 7 Ventilator.
| Device ID | K912619 |
| 510k Number | K912619 |
| Device Name: | BEAR 7 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Lee Adair |
| Correspondent | Lee Adair BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-13 |
| Decision Date | 1992-06-11 |