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FDA 510(k) Application Details - K021135
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K021135
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
JOELLE NEIDER
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
04/09/2002
Decision Date
05/09/2002
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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