The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Magpro, Model R30.
| Device ID | K061645 |
| 510k Number | K061645 |
| Device Name: | MAGPRO, MODEL R30 |
| 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 | 2006-06-12 |
| Decision Date | 2006-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713484020215 | K061645 | 000 |
| 05713484031242 | K061645 | 000 |
| 05713484030726 | K061645 | 000 |
| 05713484030702 | K061645 | 000 |
| 05713484030696 | K061645 | 000 |
| 05713484030528 | K061645 | 000 |
| 05713484030221 | K061645 | 000 |
| 05713484020208 | K061645 | 000 |
| 05713484020192 | K061645 | 000 |
| 05713484031303 | K061645 | 000 |
| 05713484031310 | K061645 | 000 |
| 05713484020185 | K061645 | 000 |
| 05713484020161 | K061645 | 000 |
| 05713484020154 | K061645 | 000 |
| 05713484020086 | K061645 | 000 |
| 05713484010025 | K061645 | 000 |
| 05713484031235 | K061645 | 000 |
| 05713484030573 | K061645 | 000 |
| 05713484030061 | K061645 | 000 |
| 05713484031211 | K061645 | 000 |