The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable Adhesive Surface Electrodes, Disc Electrodes.
| Device ID | K073532 |
| 510k Number | K073532 |
| Device Name: | DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Contact | Maurice Roost |
| Correspondent | Maurice Roost TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-17 |
| Decision Date | 2008-05-01 |
| Summary: | summary |