K955335 is an FDA 510(k) clearance for the DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on January 29, 1996, 70 days after receiving the submission on November 20, 1995.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K955335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1995 |
| Decision Date | January 29, 1996 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | IKT — Electrode, Needle, Diagnostic Electromyograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1385 |