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FDA 510(k) Application Details - K011304
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K011304
Device Name
System, Monitoring, Perinatal
Applicant
ANALOGIC CORP.
360 AUDUBON RD.
WAKEFIELD, MA 01880 US
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Contact
STEVEN A CLARKE
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
04/30/2001
Decision Date
05/29/2001
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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