The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for Neuroline, Disposable Monopolar Needle Electrodes.
| Device ID | K983597 |
| 510k Number | K983597 |
| Device Name: | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES |
| Classification | Electrode, Needle |
| Applicant | MEDICOTEST, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy MEDICOTEST, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-01-11 |