DECLIPSESPECT VIEWER— 510(k) K123917

Substantially Equivalent

Surgiceye GmbH

FDA 510(k) clearance K123917 for DECLIPSESPECT VIEWER, Substantially Equivalent on 2013-01-25. 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: 2012-12-19
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.