The following data is part of a premarket notification filed by Medicotest A/s with the FDA for Neuroline, Subdermal Needle Electrodes.
| Device ID | K020907 |
| 510k Number | K020907 |
| Device Name: | NEUROLINE, SUBDERMAL NEEDLE ELECTRODES |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | MEDICOTEST A/S 1800 MASSCHUSETTS AVE., N.W. SUITE 200 Washington, DC 20036 -1221 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy MEDICOTEST A/S 1800 MASSCHUSETTS AVE., N.W. SUITE 200 Washington, DC 20036 -1221 |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-20 |
| Decision Date | 2002-06-14 |