The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Mofification Bear Nvm-1 Neonatal Volume Monitor.
| Device ID | K890724 |
| 510k Number | K890724 |
| Device Name: | MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Kaoru Lee |
| Correspondent | Kaoru Lee 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 | 1989-02-13 |
| Decision Date | 1989-03-30 |