The following data is part of a premarket notification filed by Sentec Inc. with the FDA for Sentec Digital Monitor Model #sdm.
| Device ID | K041548 |
| 510k Number | K041548 |
| Device Name: | SENTEC DIGITAL MONITOR MODEL #SDM |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | SENTEC INC. S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen Gorski |
| Correspondent | Stephen Gorski SENTEC INC. S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-09 |
| Decision Date | 2004-08-09 |
| Summary: | summary |