HEARING AID TEST SYSTEM MODEL HAT 1000— 510(k) K870229

Name: FDA 510(k) clearance K870229
Creator: U.S. Food and Drug Administration
Published: 1987-03-13

Substantially Equivalent

Madsen Electronics (Canada) , Ltd.

FDA 510(k) clearance K870229 for HEARING AID TEST SYSTEM MODEL HAT 1000, Substantially Equivalent on 1987-03-13. Applicant: Madsen Electronics (Canada) , Ltd.. Device class: 2.

Clearance details

Applicant: Madsen Electronics (Canada) , Ltd.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1987-01-21
Decision date: 1987-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, Ontario, CA

Download summary PDF View on FDA.gov ↗

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