The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for Disposible Eeg Needle Electrodes.
| Device ID | K901280 |
| 510k Number | K901280 |
| Device Name: | DISPOSIBLE EEG NEEDLE ELECTRODES |
| Classification | Electrode, Needle |
| Applicant | MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
| Contact | John I Alber |
| Correspondent | John I Alber MEDICOTEST, INC. ONE METROPOLITAN SQUARE 211 NORTH BROADWAY, SUITE 3600 St. Louis, MO 63102 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-19 |
| Decision Date | 1990-05-11 |