The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Disposable Pressure Manometer (dpm).
| Device ID | K143148 |
| 510k Number | K143148 |
| Device Name: | Disposable Pressure Manometer (DPM) |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | Westmed, Inc. 5580 S. Nogales Hwy. Tucson, AZ 85706 |
| Contact | Diana Upp |
| Correspondent | Paul Dryden Westmed, Inc. 5580 S. Nogales Hwy. Tucson, AZ 85706 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-08-11 |
| Summary: | summary |