ACCUSONIC ADVANTAGE— 510(k) K124010

Name: FDA 510(k) clearance K124010
Creator: U.S. Food and Drug Administration
Published: 2013-08-23

Substantially Equivalent

Metron Medical Australia, Pty, Ltd.

FDA 510(k) clearance K124010 for ACCUSONIC ADVANTAGE, Substantially Equivalent on 2013-08-23. Applicant: Metron Medical Australia, Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Metron Medical Australia, Pty, Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2012-12-27
Decision date: 2013-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrum Downs, AU

Download summary PDF View on FDA.gov ↗

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