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FDA 510(k) Application Details - K964770
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K964770
Device Name
System, Monitoring, Perinatal
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD, CT 06492 US
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Contact
MARIA VITUG FOUTS
Other 510(k) Applications for this Contact
Regulation Number
884.2740
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Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/27/1996
Decision Date
02/21/1997
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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