FDA 510(k) Application Details - K991739

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K991739
Device Name System, Monitoring, Perinatal
Applicant GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
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 05/21/1999
Decision Date 08/19/1999
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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