FDA 510(k) Application Details - K131457

Device Classification Name Monitor, Ultrasonic, Fetal

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510(K) Number K131457
Device Name Monitor, Ultrasonic, Fetal
Applicant SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
4TH FLOOR, JINHUI BUILDING, NANHAI BLVD
NANSHAN DISTRICT
SHENZHEN, GUANGDONG 518052 CN
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Contact FIELD FU
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Regulation Number 884.2660

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Classification Product Code KNG
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Date Received 05/20/2013
Decision Date 01/24/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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