Name: Predicase
Price: 199 USD

K-number	K231970
Device name	PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock
Applicant	Pentax of America, Inc.
Product code	EOQ
Device class	Class II
Decision date	Jan 12, 2024
Decision	Substantially Equivalent
Regulation	874.4680

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Source

View the full FDA submission: accessdata.fda.gov

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PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

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