The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable Hypodermic Emg Needle Electrode Technomed Europe Version And Private Labeled.
Device ID | K062437 |
510k Number | K062437 |
Device Name: | DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED |
Classification | Electrode, Needle, Diagnostic Electromyograph |
Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
Contact | Rene Roncken |
Correspondent | Rene Roncken TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
Product Code | IKT |
CFR Regulation Number | 890.1385 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-11 |
Decision Date | 2007-02-16 |
Summary: | summary |