The following data is part of a premarket notification filed by Neurent Medical with the FDA for Neuromark System.
| Device ID | K212666 |
| 510k Number | K212666 |
| Device Name: | Neuromark System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Neurent Medical 1 Oran Point, Main Street, Oranmore Galway, IE H91d7x2 |
| Contact | Kenny Walsh |
| Correspondent | Kenny Walsh 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 | 2021-08-23 |
| Decision Date | 2021-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391537940026 | K212666 | 000 |
| 05391537940002 | K212666 | 000 |