The following data is part of a premarket notification filed by Medicotest A/s with the FDA for Neuroline, Disposable Concentric Needle Electrodes.
| Device ID | K973529 |
| 510k Number | K973529 |
| Device Name: | NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | MEDICOTEST A/S 1900 K ST. N.W. Washington, DC 20006 -1108 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy MEDICOTEST A/S 1900 K ST. N.W. Washington, DC 20006 -1108 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1997-11-20 |