K955931 is an FDA 510(k) clearance for the MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION). This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Advanced Medical Systems, Inc. (Hamden, US). The FDA issued a Cleared decision on August 14, 1996, 243 days after receiving the submission on December 15, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K955931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1995 |
| Decision Date | August 14, 1996 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGM — System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |