510(k) K131457
K131457 is an FDA 510(k) premarket notification submitted by Shenzhen Jumper Medical Equipment Co., Ltd. for the device "FETAL ULTRASONIC MONITOR AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 24, 2014. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Shenzhen Jumper Medical Equipment Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2014
- Date Received
- May 20, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Ultrasonic, Fetal
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type