MAMMI— 510(k) K140996

Name: FDA 510(k) clearance K140996
Creator: U.S. Food and Drug Administration
Published: 2014-06-11

Substantially Equivalent

General Equipment For Medical Imaging (Oncovision-

FDA 510(k) clearance K140996 for MAMMI, Substantially Equivalent on 2014-06-11. Applicant: General Equipment For Medical Imaging (Oncovision-. Device class: 2.

Clearance details

Applicant: General Equipment For Medical Imaging (Oncovision-
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2014-04-17
Decision date: 2014-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, ES

Download summary PDF View on FDA.gov ↗

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