The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for Disposable Neurology Electrodes Neuroline 7 30 01-k.
| Device ID | K952176 |
| 510k Number | K952176 |
| Device Name: | DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K |
| Classification | Electrode, Cutaneous |
| Applicant | MEDICOTEST, INC. ONE METROPOLITA SQUARE 211 NORTH BROADWAY, STE. 3600 St. Louis, MO 63102 -2750 |
| Contact | Randy R Mariani |
| Correspondent | Randy R Mariani MEDICOTEST, INC. ONE METROPOLITA SQUARE 211 NORTH BROADWAY, STE. 3600 St. Louis, MO 63102 -2750 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-09-25 |