The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Pro 2 Monitor, Pro 2 Sensor, Pro2 Holder, Pro2 Neonate Holder, Models, Pro- 200, Ans-200, Ahl-200, Nhl-200.
| Device ID | K032831 |
| 510k Number | K032831 |
| Device Name: | PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-11 |
| Decision Date | 2004-08-31 |
| Summary: | summary |