The following data is part of a premarket notification filed by Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh with the FDA for Neuromuscular Transmission Monitor Tof3d.
| Device ID | K212434 |
| 510k Number | K212434 |
| Device Name: | Neuromuscular Transmission Monitor TOF3D |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | MIPM Mammendorfer Institut Für Physik Und Medizin GmbH Oskar-von-Miller Str. 6 Mammendorf, DE 82291 |
| Contact | Jennifer Rosenheimer |
| Correspondent | Lukas Spögler MIPM Mammendorfer Institut Für Physik Und Medizin GmbH Oskar-von-Miller Str. 6 Mammendorf, DE 82291 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2022-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EMIP5750110A0 | K212434 | 000 |
| 04255629200393 | K212434 | 000 |
| 04255629200409 | K212434 | 000 |
| 04255629200416 | K212434 | 000 |
| 04255629200430 | K212434 | 000 |
| 04255629200447 | K212434 | 000 |
| 04255629200461 | K212434 | 000 |
| 04255629200478 | K212434 | 000 |
| 04255629200775 | K212434 | 000 |
| EMIP25100910 | K212434 | 000 |
| EMIP57501000 | K212434 | 000 |
| EMIP57501010 | K212434 | 000 |
| EMIP57501020 | K212434 | 000 |
| EMIP57501060 | K212434 | 000 |
| 04255629200904 | K212434 | 000 |