Name: Predicase
Price: 199 USD

K-number	K230991
Device name	PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Applicant	Given Imaging Ltd. (Medtronic)
Product code	NEZ
Device class	Class II
Decision date	Jun 30, 2023
Decision	Substantially Equivalent
Regulation	876.1300

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Everything you need for a 510(k) submission. Nothing you don't.