FDA 510(k) Application Details - K173042

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K173042
Device Name System, Monitoring, Perinatal
Applicant Edan Instruments, Inc
#15 Jinhui Road, Jinsha Community
Kengzi Sub-District, Pingshan District
Shenzhen 518122 CN
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Contact Alice Yang
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 09/28/2017
Decision Date 08/30/2018
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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