The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for K-10-vs, Da-05-vs, Recording Electrodes.
| Device ID | K941568 |
| 510k Number | K941568 |
| Device Name: | K-10-VS, DA-05-VS, RECORDING ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | MEDICOTEST, INC. RUGMARKEN 10 Dk3650 Olstykke, DK |
| Contact | Randy R Mariani |
| Correspondent | Randy R Mariani MEDICOTEST, INC. RUGMARKEN 10 Dk3650 Olstykke, DK |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-31 |
| Decision Date | 1994-11-04 |