Name: Predicase
Price: 199 USD

K-number	K191282
Device name	PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
Applicant	Pentax of America, Inc.
Product code	PEA
Device class	Class II
Decision date	Nov 8, 2019
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 EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family

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