FETAL ULTRASONIC MONITOR AND ACCESSORIES— 510(k) K131457

Name: FDA 510(k) clearance K131457
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Substantially Equivalent

Shenzhen Jumper Medical Equipment Co., Ltd.

FDA 510(k) clearance K131457 for FETAL ULTRASONIC MONITOR AND ACCESSORIES, Substantially Equivalent on 2014-01-24. Applicant: Shenzhen Jumper Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Jumper Medical Equipment Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2013-05-20
Decision date: 2014-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdon, CN

Download summary PDF View on FDA.gov ↗

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