The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable And Reusable Concentric Needle Electrodes,disposable And Reusable Subdermal Needle Electrodes,.
| Device ID | K130136 |
| 510k Number | K130136 |
| Device Name: | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, |
| Classification | Electrode, Needle |
| Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Contact | Pierre Vreuls |
| Correspondent | Pierre Vreuls TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-18 |
| Decision Date | 2013-07-19 |
| Summary: | summary |