K-number	K170210
Device name	PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
Applicant	Given Imaging , Ltd.
Product code	NEZ
Device class	Class II
Decision date	Sep 1, 2017
Decision	Substantially Equivalent
Regulation	876.1300

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Source

View the full FDA submission: accessdata.fda.gov

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PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0

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