FDA 510(k) Application Details - K993008

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K993008
Device Name System, Monitoring, Perinatal
Applicant MARQUETTE MEDICAL SYSTEMS, INC.
200 HARRY SOUTH TRUMAN PKWY.
SUITE 220
ANNAPOLIS, MD 21401 US
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Contact MARIA VITUG FOUTS
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 09/07/1999
Decision Date 12/06/1999
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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