The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear Nvm-1.
| Device ID | K872660 |
| 510k Number | K872660 |
| Device Name: | BEAR NVM-1 |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| 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 | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-07 |
| Decision Date | 1988-02-12 |