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 |