K003508 is an FDA 510(k) clearance for the NC-STAT. This device is classified as a Device, Nerve Conduction Velocity Measurement (Class II - Special Controls, product code JXE).
Submitted by Neurometrix, Inc. (North Attleboro, US). The FDA issued a Cleared decision on January 17, 2001, 64 days after receiving the submission on November 14, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1550.
| 510(k) Number | K003508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2000 |
| Decision Date | January 17, 2001 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXE - Device, Nerve Conduction Velocity Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1550 |