K894911 is an FDA 510(k) clearance for the SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on May 14, 1990, 286 days after receiving the submission on August 1, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K894911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1989 |
| Decision Date | May 14, 1990 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |