The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear 3 Ventilator.
| Device ID | K881335 |
| 510k Number | K881335 |
| Device Name: | BEAR 3 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Mike Collins |
| Correspondent | Mike Collins 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 | 1988-03-29 |
| Decision Date | 1988-08-04 |