Name: Predicase
Price: 199 USD

K-number	K181472
Device name	AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
Applicant	Advanced Sterilization Products (Asp)
Product code	FEB
Device class	Class II
Decision date	Apr 23, 2019
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor

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