SENTINELLA 102— 510(k) K110601

Name: FDA 510(k) clearance K110601
Creator: U.S. Food and Drug Administration
Published: 2011-03-18

Substantially Equivalent

General Equipment For Medical Imaging, S.A.

FDA 510(k) clearance K110601 for SENTINELLA 102, Substantially Equivalent on 2011-03-18. Applicant: General Equipment For Medical Imaging, S.A.. Device class: 1.

Clearance details

Applicant: General Equipment For Medical Imaging, S.A.
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2011-03-02
Decision date: 2011-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, ES

Download summary PDF View on FDA.gov ↗

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