Name: Predicase
Price: 199 USD

K-number	K162447
Device name	PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
Applicant	Pentax of America, Inc.
Product code	ODG
Device class	Class II
Decision date	Apr 13, 2017
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner

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