The following data is part of a premarket notification filed by Sentec Ag with the FDA for Sentec Digital Monitor, Oxivent Sensor, V-sign Sensor, Staysite Adhesive Pad, V-stats Pc Software Including V-carenet.
| Device ID | K151329 |
| 510k Number | K151329 |
| Device Name: | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software Including V-CareNet |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | SENTEC AG RINGSTRASSE 39 Therwil, CH 4106 |
| Contact | Anke Weisbrich |
| Correspondent | Stephen H Gorski IMAGENIX, INC. S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | LKD |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | KLK |
| Subsequent Product Code | LPP |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-12-17 |
| Summary: | summary |