FDA 510(k) Application Details - K023618

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K023618
Device Name System, Monitoring, Perinatal
Applicant OXFORD INSTRUMENTS MEDICAL LTD.
MANOR WAY
OLD WOKING, SURREY GU22 9JU GB
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Contact MICHAEL EDWARDS
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 10/29/2002
Decision Date 01/22/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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