K131457 is an FDA 510(k) clearance for the FETAL ULTRASONIC MONITOR AND ACCESSORIES. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Shenzhen Jumper Medical Equipment Co., Ltd. (Shenzhen, Guangdon, CN). The FDA issued a Cleared decision on January 24, 2014, 249 days after receiving the submission on May 20, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K131457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2013 |
| Decision Date | January 24, 2014 |
| Days to Decision | 249 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 |