K062580 is an FDA 510(k) clearance for the GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on December 21, 2007, 477 days after receiving the submission on August 31, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K062580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2006 |
| Decision Date | December 21, 2007 |
| Days to Decision | 477 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |