K891595 is an FDA 510(k) clearance for the MODEL 116 FETAL MONITOR. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on June 12, 1989, 84 days after receiving the submission on March 20, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K891595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1989 |
| Decision Date | June 12, 1989 |
| Days to Decision | 84 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 |