The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Neurometrix Advance.
| Device ID | K070109 |
| 510k Number | K070109 |
| Device Name: | NEUROMETRIX ADVANCE |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451 |
| Contact | Rainer N Maas |
| Correspondent | Rainer N Maas 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 | 2007-01-11 |
| Decision Date | 2008-04-25 |
| Summary: | summary |