The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Coils, Models Mcf-b65, Mcf-75, Mcf-125 And Cool-b65.
| Device ID | K071821 |
| 510k Number | K071821 |
| Device Name: | COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713484020130 | K071821 | 000 |
| 05713484020123 | K071821 | 000 |
| 05713484020116 | K071821 | 000 |
| 05713484020093 | K071821 | 000 |
| 05713484020055 | K071821 | 000 |
| 05713484020031 | K071821 | 000 |
| 05713484020024 | K071821 | 000 |