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FDA 510(k) Application Details - K173459
Device Classification Name
System, Imaging, Gastrointestinal, Wireless, Capsule
More FDA Info for this Device
510(K) Number
K173459
Device Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi 192-8507 JP
Other 510(k) Applications for this Company
Contact
Toshiyuki Nakajima
Other 510(k) Applications for this Contact
Regulation Number
876.1300
More FDA Info for this Regulation Number
Classification Product Code
NEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/2017
Decision Date
03/13/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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