MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100— 510(k) K011955

Name: FDA 510(k) clearance K011955
Creator: U.S. Food and Drug Administration
Published: 2001-07-16

Substantially Equivalent

Metron Medical Australia, Pty, Ltd.

FDA 510(k) clearance K011955 for MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100, Substantially Equivalent on 2001-07-16. 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: 2001-06-22
Decision date: 2001-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Carrum Downs, AU

Download summary PDF View on FDA.gov ↗

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