The following data is part of a premarket notification filed by Sentec Ag with the FDA for Sentec Digital Monitor, V-sign Sensor And V-sign Sensor 2 With Digital Sensor Adaper Cable.
| Device ID | K101690 |
| 510k Number | K101690 |
| Device Name: | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| 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 | LKD |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-16 |
| Decision Date | 2010-12-03 |
| Summary: | summary |