K110630 is an FDA 510(k) clearance for the F10. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Mediana Co., Ltd. (Wonju-City, Gangwon-Do, KR). The FDA issued a Cleared decision on June 24, 2011, 113 days after receiving the submission on March 3, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K110630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2011 |
| Decision Date | June 24, 2011 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNG - Monitor, Ultrasonic, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |