The following data is part of a premarket notification filed by Caradyne, Ltd. with the FDA for Criterion 40 Or Pm 40.
| Device ID | K992101 |
| 510k Number | K992101 |
| Device Name: | CRITERION 40 OR PM 40 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden CARADYNE, LTD. 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 | 1999-06-22 |
| Decision Date | 2000-01-06 |
| Summary: | summary |