The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Mep Monitor.
| Device ID | K162873 |
| 510k Number | K162873 |
| Device Name: | MEP Monitor |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 Farum, DK 3520 |
| Contact | Lise Terkelsen |
| Correspondent | Lise Terkelsen TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 Farum, DK 3520 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-13 |
| Decision Date | 2017-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713484030429 | K162873 | 000 |