CONFIDENT SURGERY SUITE 300, MODEL CSS300— 510(k) K101887

Name: FDA 510(k) clearance K101887
Creator: U.S. Food and Drug Administration
Published: 2011-03-22

Substantially Equivalent

Surgiceye GmbH

FDA 510(k) clearance K101887 for CONFIDENT SURGERY SUITE 300, MODEL CSS300, Substantially Equivalent on 2011-03-22. Applicant: Surgiceye GmbH. Device class: 1.

Clearance details

Applicant: Surgiceye GmbH
Product code: Code IZD
Device class: Class 1
Regulation: 21 CFR 892.1320
Advisory panel: Radiology
Date received: 2010-07-06
Decision date: 2011-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, Bavaria, DE

Download summary PDF View on FDA.gov ↗

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