FDA 510(k) Application Details - K992607

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K992607
Device Name System, Monitoring, Perinatal
Applicant OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 08/03/1999
Decision Date 04/27/2001
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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