Name: Predicase
Price: 199 USD

K-number	K173554
Device name	PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
Applicant	Pentax of America, Inc.
Product code	EOQ
Device class	Class II
Decision date	Jan 19, 2018
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 Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

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