K150901 is an FDA 510(k) clearance for the Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2015, 89 days after receiving the submission on April 3, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K150901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2015 |
| Decision Date | July 01, 2015 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGM — System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |