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FDA 510(k) Application Details - K072976
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K072976
Device Name
System, Monitoring, Perinatal
Applicant
GE HEALTHCARE
8880 GORMAN RD
LAUREL, MD 20723 US
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Contact
AGATA SMIEJA
Other 510(k) Applications for this Contact
Regulation Number
884.2740
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Classification Product Code
HGM
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More FDA Info for this Product Code
Date Received
10/25/2007
Decision Date
12/20/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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