K-number	K230560
Device name	enspire 300 Series Automated Endoscope Reprocessor System
Applicant	STERIS Corporation
Product code	NZA
Device class	Class II
Decision date	Jul 21, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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enspire 300 Series Automated Endoscope Reprocessor System

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