FDA 510(k) Application Details - K150901

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K150901
Device Name System, Monitoring, Perinatal
Applicant EDAN INSTRUMENTS, INC.
3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI ROAD #1019
SHENZHEN 518067 CN
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Contact Queena Chen
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 04/03/2015
Decision Date 07/01/2015
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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