Name: Predicase
Price: 199 USD

K-number	K221608
Device name	NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
Applicant	Anx Robotica Corp
Product code	QKZ
Device class	Class II
Decision date	Nov 22, 2022
Decision	Substantially Equivalent
Regulation	876.1310

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Source

View the full FDA submission: accessdata.fda.gov

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

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