K790139 is an FDA 510(k) clearance for the MONITOR, OFFICE MODEL 140. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on February 16, 1979, 28 days after receiving the submission on January 19, 1979.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K790139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1979 |
| Decision Date | February 16, 1979 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | HGM - System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |