ACCOUSONIC PLUS, MODEL AP-170— 510(k) K030410

Name: FDA 510(k) clearance K030410
Creator: U.S. Food and Drug Administration
Published: 2003-02-20

Substantially Equivalent

Metron Medical Australia, Pty, Ltd.

FDA 510(k) clearance K030410 for ACCOUSONIC PLUS, MODEL AP-170, Substantially Equivalent on 2003-02-20. 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: 2003-02-07
Decision date: 2003-02-20
Decision: Substantially Equivalent
Clearance type: Special
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.