AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020— 510(k) K874354

Name: FDA 510(k) clearance K874354
Creator: U.S. Food and Drug Administration
Published: 1988-01-27

Substantially Equivalent

Madsen Electronics (Canada) , Ltd.

FDA 510(k) clearance K874354 for AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020, Substantially Equivalent on 1988-01-27. 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: 1987-10-23
Decision date: 1988-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, Ontario, CA

Download summary PDF View on FDA.gov ↗

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