AEROSYNC FOR AERODR SYSTEM— 510(k) K120477

Name: FDA 510(k) clearance K120477
Creator: U.S. Food and Drug Administration
Published: 2012-04-09

Substantially Equivalent

Konica Minolta Medical & Graphic, Inc.

FDA 510(k) clearance K120477 for AEROSYNC FOR AERODR SYSTEM, Substantially Equivalent on 2012-04-09. Applicant: Konica Minolta Medical & Graphic, Inc.. Device class: 2.

Clearance details

Applicant: Konica Minolta Medical & Graphic, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2012-02-16
Decision date: 2012-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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