K904935 is an FDA 510(k) clearance for the RESPIRONICS' DIGITAL MANOMETER. This device is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II - Special Controls, product code CAP).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on April 3, 1991, 153 days after receiving the submission on November 1, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.
| 510(k) Number | K904935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1990 |
| Decision Date | April 03, 1991 |
| Days to Decision | 153 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 |