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FDA 510(k) Application Details - K121267
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K121267
Device Name
System, Monitoring, Perinatal
Applicant
BISTOS CO., LTD.
111 ELLISON STREET
PATERSON, NJ 07505 US
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Contact
YOUNG CHI
Other 510(k) Applications for this Contact
Regulation Number
884.2740
More FDA Info for this Regulation Number
Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/2012
Decision Date
08/02/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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