K871139 is an FDA 510(k) clearance for the M-10 VENTILATION MONITOR. This device is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II - Special Controls, product code CAP).
Submitted by Bio-Med Devices, Inc. (Madison, US). The FDA issued a Cleared decision on April 21, 1987, 29 days after receiving the submission on March 23, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.
| 510(k) Number | K871139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1987 |
| Decision Date | April 21, 1987 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CAP - Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2600 |