The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics' Digital Manometer.
| Device ID | K904935 |
| 510k Number | K904935 |
| Device Name: | RESPIRONICS' DIGITAL MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Eugene N Scarberry |
| Correspondent | Eugene N Scarberry RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-01 |
| Decision Date | 1991-04-03 |