ZODIAC 901 MIDDLE-EAR ANALYZER— 510(k) K910247

Name: FDA 510(k) clearance K910247
Creator: U.S. Food and Drug Administration
Published: 1991-06-19

Substantially Equivalent

Madsen Electronics (Canada) , Ltd.

FDA 510(k) clearance K910247 for ZODIAC 901 MIDDLE-EAR ANALYZER, Substantially Equivalent on 1991-06-19. 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: 1991-01-22
Decision date: 1991-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Tonawanda, NY, US

Download summary PDF View on FDA.gov ↗

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