K871336 is an FDA 510(k) clearance for the M-1 PRESSURE 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 June 5, 1987, 63 days after receiving the submission on April 3, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.
| 510(k) Number | K871336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1987 |
| Decision Date | June 05, 1987 |
| Days to Decision | 63 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 |