Name: Predicase
Price: 199 USD

K-number	K231960
Device name	NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
Applicant	Anx Robotica Corporation
Product code	QKZ
Device class	Class II
Decision date	Oct 3, 2023
Decision	Substantially Equivalent
Regulation	876.1310

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Source

View the full FDA submission: accessdata.fda.gov

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NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether

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