FDA 510(k) Application Details - K110124

Device Classification Name Monitor, Ultrasonic, Fetal

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510(K) Number K110124
Device Name Monitor, Ultrasonic, Fetal
Applicant SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
P.O. BOX 237-023
SHANGHAI 200237 CN
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Contact DIANA HONG
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Regulation Number 884.2660

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Classification Product Code KNG
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Date Received 01/18/2011
Decision Date 02/04/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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