The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for M-10 Ventilation Monitor.
| Device ID | K871139 |
| 510k Number | K871139 |
| Device Name: | M-10 VENTILATION MONITOR |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | BIO-MED DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
| Contact | Dean J Bennett |
| Correspondent | Dean J Bennett BIO-MED DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-23 |
| Decision Date | 1987-04-21 |