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FDA 510(k) Application Details - K110556
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K110556
Device Name
System, Monitoring, Perinatal
Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 GOMAN ROAD
LAUREL, MD 20723-5800 US
Other 510(k) Applications for this Company
Contact
AGATA SMIEJA
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
02/28/2011
Decision Date
07/19/2011
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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