The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Modification To Nc-stat.
| Device ID | K000565 |
| 510k Number | K000565 |
| Device Name: | MODIFICATION TO NC-STAT |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | NEUROMETRIX, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte NEUROMETRIX, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851221006315 | K000565 | 000 |
| 00851221006308 | K000565 | 000 |
| 00851221006186 | K000565 | 000 |
| 00851221006179 | K000565 | 000 |
| 10851221006169 | K000565 | 000 |
| 00851221006155 | K000565 | 000 |