K890710 is an FDA 510(k) clearance for the DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Somatics, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on March 14, 1989, 29 days after receiving the submission on February 13, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K890710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1989 |
| Decision Date | March 14, 1989 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |