The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Td50 Electromyograph.
| Device ID | K935017 |
| 510k Number | K935017 |
| Device Name: | TD50 ELECTROMYOGRAPH |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Contact | J. B. Holloway |
| Correspondent | J. B. Holloway MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-19 |
| Decision Date | 1994-07-28 |