The following data is part of a premarket notification filed by Medelec Intl. Corp. with the FDA for Disposable Needle Electrode.
| Device ID | K961013 |
| 510k Number | K961013 |
| Device Name: | DISPOSABLE NEEDLE ELECTRODE |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Contact | Jeff Hall |
| Correspondent | Jeff Hall MEDELEC INTL. CORP. MANOR WAY OLD WOKING, SURREY GU22 9JU England, GB |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-13 |
| Decision Date | 1996-12-20 |