The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Modification Of Nc-stat.
| Device ID | K013459 |
| 510k Number | K013459 |
| Device Name: | MODIFICATION OF NC-STAT |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | NEUROMETRIX, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Shiela Hemeon-heyer |
| Correspondent | Shiela Hemeon-heyer 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 | 2001-10-18 |
| Decision Date | 2002-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851221006145 | K013459 | 000 |
| 10851221006138 | K013459 | 000 |
| 10851221006107 | K013459 | 000 |
| 00851221006094 | K013459 | 000 |