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 |