enspire 300 Series Automated Endoscope Reprocessor System— 510(k) K230560

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K230560 for enspire 300 Series Automated Endoscope Reprocessor System, Substantially Equivalent on 2023-07-21. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant
STERIS Corporation
Product code
Code NZA
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mentor, OH, US
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