The following data is part of a premarket notification filed by Neurent Medical with the FDA for Neuromark System.
| Device ID | K222032 |
| 510k Number | K222032 |
| Device Name: | NEUROMARK System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Neurent Medical 1 Oran Point, Main Street, Oranmore Galway, IE H91D7X2 |
| Contact | Karen E. Peterson |
| Correspondent | Karen E. Peterson Neurent Medical 1 Oran Point, Main Street, Oranmore Galway, IE H91D7X2 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-11 |
| Decision Date | 2022-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391537940118 | K222032 | 000 |
| 05391537940095 | K222032 | 000 |