The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Monitor, Airway Pressure.
| Device ID | K802955 |
| 510k Number | K802955 |
| Device Name: | MONITOR, AIRWAY PRESSURE |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-20 |
| Decision Date | 1980-12-19 |