K212434 is an FDA 510(k) clearance for the Neuromuscular Transmission Monitor TOF3D. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by MIPM Mammendorfer Institut f?r Physik und Medizin GmbH (Mammendorf, DE). The FDA issued a Cleared decision on May 5, 2022, 274 days after receiving the submission on August 4, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K212434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2021 |
| Decision Date | May 05, 2022 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KOI - Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |