Submission Details
| 510(k) Number | K990015 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 04, 1999 |
| Decision Date | May 27, 1999 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
ELECTRODE NEEDLES
May 1999
Decision
143d
Days
Class 2
Risk
About This 510(k) Submission
K990015 is an FDA 510(k) clearance for the ELECTRODE NEEDLES, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Technomed Europe (6191 Bg Beek, NL). The FDA issued a Cleared decision on May 27, 1999, 143 days after receiving the submission on January 4, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.
Device Classification
| Product Code | IKT — Electrode, Needle, Diagnostic Electromyograph |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.1385 |
Manufacturer
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