FDA 510(k) Application Details - K103545

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K103545
Device Name System, Monitoring, Perinatal
Applicant BISTOS CO., LTD.
4802 GLENWOOD ROAD
BROOKLYN, NY 11234 US
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Contact STEVE KOHN
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 12/02/2010
Decision Date 05/13/2011
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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