The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Modification To Nc-stat.
| Device ID | K041320 |
| 510k Number | K041320 |
| Device Name: | MODIFICATION TO NC-STAT |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451 |
| Contact | Joseph F Burke |
| Correspondent | Joseph F Burke NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-18 |
| Decision Date | 2004-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851221006206 | K041320 | 000 |
| 00816022023664 | K041320 | 000 |
| 00816022023671 | K041320 | 000 |
| 00816022023688 | K041320 | 000 |
| 00816022023695 | K041320 | 000 |
| 00816022023701 | K041320 | 000 |
| 00816022023718 | K041320 | 000 |
| 20851221006081 | K041320 | 000 |
| 10851221006114 | K041320 | 000 |
| 10851221006121 | K041320 | 000 |
| 10851221006190 | K041320 | 000 |
| 00816022023657 | K041320 | 000 |