Z0174, IMPEDANCE AUDIOMETER— 510(k) K845049

Name: FDA 510(k) clearance K845049
Creator: U.S. Food and Drug Administration
Published: 1985-05-21

Substantially Equivalent

Madsen Electronics (Canada) , Ltd.

FDA 510(k) clearance K845049 for Z0174, IMPEDANCE AUDIOMETER, Substantially Equivalent on 1985-05-21. Applicant: Madsen Electronics (Canada) , Ltd.. Device class: 2.

Clearance details

Applicant: Madsen Electronics (Canada) , Ltd.
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 1984-11-26
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, Ontario, CA

Download summary PDF View on FDA.gov ↗

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