K841477 is an FDA 510(k) clearance for the COROMETRICS 815 FETAL ECG RECORDER. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Ge Medical Systems Information Technologies (Walker, US). The FDA issued a Cleared decision on May 14, 1984, 35 days after receiving the submission on April 9, 1984.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K841477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1984 |
| Decision Date | May 14, 1984 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HGM - System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |