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FDA 510(k) Application Details - K071153
Device Classification Name
System, Imaging, Esophageal, Wireless, Capsule
More FDA Info for this Device
510(K) Number
K071153
Device Name
System, Imaging, Esophageal, Wireless, Capsule
Applicant
GIVEN IMAGING LTD.
91 ROCKYSPRING CIRCLE NW
CALGARY, ALBERTA T3G 6A1 CA
Other 510(k) Applications for this Company
Contact
SHOSHANA FRIEDMAN
Other 510(k) Applications for this Contact
Regulation Number
876.1300
More FDA Info for this Regulation Number
Classification Product Code
NSI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/2007
Decision Date
06/11/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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