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 |