The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Conmed Pro2 Pulse Reflectance Oximeter, Model Pro-m.
| Device ID | K061112 |
| 510k Number | K061112 |
| Device Name: | CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M |
| Classification | Oximeter |
| Applicant | CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Contact | Ira Duesler |
| Correspondent | Ira Duesler CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-21 |
| Decision Date | 2006-05-22 |
| Summary: | summary |