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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, ultrasonic, fetal
510(k) Number K131457
Device Name FETAL ULTRASONIC MONITOR AND ACCESSORIES
Applicant
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD
NANSHAN DISTRICT
SHENZHEN, GUANGDONG,  CN 518052
Applicant Contact FIELD FU
Correspondent
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD
NANSHAN DISTRICT
SHENZHEN, GUANGDONG,  CN 518052
Correspondent Contact FIELD FU
Regulation Number884.2660
Classification Product Code
KNG  
Date Received05/20/2013
Decision Date 01/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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