SONIC, MODEL SO-100— 510(k) K000593

Name: FDA 510(k) clearance K000593
Creator: U.S. Food and Drug Administration
Published: 2000-08-04

Substantially Equivalent

Metron Medical Australia, Pty, Ltd.

FDA 510(k) clearance K000593 for SONIC, MODEL SO-100, Substantially Equivalent on 2000-08-04. 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: 2000-02-22
Decision date: 2000-08-04
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.