The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear Cub 750 Psv.
| Device ID | K992788 |
| 510k Number | K992788 |
| Device Name: | BEAR CUB 750 PSV |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Darryl Shelby |
| Correspondent | Darryl Shelby BEAR MEDICAL SYSTEMS, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-19 |
| Decision Date | 1999-09-16 |
| Summary: | summary |