The following data is part of a premarket notification filed by Respironics Georgia, Inc. with the FDA for Profox Software, Model 920m-41.
| Device ID | K001708 |
| 510k Number | K001708 |
| Device Name: | PROFOX SOFTWARE, MODEL 920M-41 |
| Classification | Oximeter |
| Applicant | RESPIRONICS GEORGIA, INC. 1255 KENNESTONE CIRCLE Marietta, GA 30066 |
| Contact | Gerry Richardson |
| Correspondent | Gerry Richardson RESPIRONICS GEORGIA, INC. 1255 KENNESTONE CIRCLE Marietta, GA 30066 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-05 |
| Decision Date | 2001-03-01 |