PillCam SB 3 Capsule Endoscopy System, PillCam Software 9.0E

System, Imaging, Gastrointestinal, Wireless, Capsule

Given Imaging Ltd. (Medtronic)

The following data is part of a premarket notification filed by Given Imaging Ltd. (medtronic) with the FDA for Pillcam Sb 3 Capsule Endoscopy System, Pillcam Software 9.0e.

Pre-market Notification Details

Device IDK211684
510k NumberK211684
Device Name:PillCam SB 3 Capsule Endoscopy System, PillCam Software 9.0E
ClassificationSystem, Imaging, Gastrointestinal, Wireless, Capsule
Applicant Given Imaging Ltd. (Medtronic) 2 Hacarmel St. New Industrial Park, PO Box 258 Yoqneam,  IL 20692
ContactEfrat Shamgar
CorrespondentRandy J. Prebula
Hogan Lovells US LLP 555 13th Street, NW Washington, Dc,  DC  20004
Product CodeNEZ  
CFR Regulation Number876.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-01
Decision Date2021-08-27

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