The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Disposable Pressure Monitor.
| Device ID | K003497 |
| 510k Number | K003497 |
| Device Name: | DISPOSABLE PRESSURE MONITOR |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2000-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720011285 | K003497 | 000 |
| 10841470111417 | K003497 | 000 |
| 10841470110892 | K003497 | 000 |
| 00026072011287 | K003497 | 000 |
| 10841470111196 | K003497 | 000 |