K935017 is an FDA 510(k) clearance for the TD50 ELECTROMYOGRAPH. This device is classified as a Device, Nerve Conduction Velocity Measurement (Class II - Special Controls, product code JXE).
Submitted by Medelec Intl. Corp. (England, GB). The FDA issued a Cleared decision on July 28, 1994, 282 days after receiving the submission on October 19, 1993.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1550.
| 510(k) Number | K935017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1993 |
| Decision Date | July 28, 1994 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | JXE — Device, Nerve Conduction Velocity Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1550 |