FDA 510(k) Application Details - K001882

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K001882
Device Name System, Monitoring, Perinatal
Applicant HUNTLEIGH HEALTHCARE, INC.
40 CHRISTOPHER WAY
EATONTOWN, NJ 07724-3327 US
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Contact AUDREY A WITKO
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 06/21/2000
Decision Date 09/19/2000
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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