K792669 is an FDA 510(k) clearance for the COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE. This device is classified as a Electrode, Circular (spiral), Scalp And Applicator (Class II - Special Controls, product code HGP).
Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on February 11, 1980, 46 days after receiving the submission on December 27, 1979.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2675.
| 510(k) Number | K792669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1979 |
| Decision Date | February 11, 1980 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HGP - Electrode, Circular (spiral), Scalp And Applicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2675 |