The following data is part of a premarket notification filed by Caradyne, Ltd. with the FDA for Criterion 60 Or Pm 60.
| Device ID | K000959 |
| 510k Number | K000959 |
| Device Name: | CRITERION 60 OR PM 60 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-06-22 |