K190795 is an FDA 510(k) clearance for the Tetragraph Neuromuscular Transmission Monitor. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by Senzime AB (Uppsala, SE). The FDA issued a Cleared decision on October 18, 2019, 204 days after receiving the submission on March 28, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K190795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 204 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 |