The following data is part of a premarket notification filed by Senzime Ab with the FDA for Tetragraph Neuromuscular Transmission Monitor.
| Device ID | K220530 |
| 510k Number | K220530 |
| Device Name: | Tetragraph Neuromuscular Transmission Monitor |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | Senzime AB Ulls Vag 41 Uppsala, SE 75651 |
| Contact | Johanna Faris |
| Correspondent | Elisa Maldonado-Holmertz Obelix Consulting 12416 Fairfax Ridge Place Austin, TX 78738 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-24 |
| Decision Date | 2022-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350012440145 | K220530 | 000 |
| 07350012440114 | K220530 | 000 |
| 07350012440107 | K220530 | 000 |