The following data is part of a premarket notification filed by Sentec Ag with the FDA for Sentec Digital Monitoring System.
| Device ID | K071672 |
| 510k Number | K071672 |
| Device Name: | SENTEC DIGITAL MONITORING SYSTEM |
| Classification | Oximeter |
| Applicant | SENTEC AG S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen H Gorski |
| Correspondent | Stephen H Gorski SENTEC AG S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-19 |
| Decision Date | 2007-09-12 |
| Summary: | summary |