The following data is part of a premarket notification filed by Technomed Europe with the FDA for Electrode Needles.
| Device ID | K990015 |
| 510k Number | K990015 |
| Device Name: | ELECTRODE NEEDLES |
| Classification | Electrode, Needle, Diagnostic Electromyograph |
| Applicant | TECHNOMED EUROPE STATIONSTRAAT 122 P.O. BOX 239 6191 Bg Beek, NL 6191 Bg |
| Contact | Harry Knuth |
| Correspondent | Harry Knuth TECHNOMED EUROPE STATIONSTRAAT 122 P.O. BOX 239 6191 Bg Beek, NL 6191 Bg |
| Product Code | IKT |
| CFR Regulation Number | 890.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-04 |
| Decision Date | 1999-05-27 |
| Summary: | summary |