The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear Vm-90 Ventilation Monitor.
| Device ID | K822912 |
| 510k Number | K822912 |
| Device Name: | BEAR VM-90 VENTILATION MONITOR |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-01 |
| Decision Date | 1982-11-16 |