HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT— 510(k) K942749

Name: FDA 510(k) clearance K942749
Creator: U.S. Food and Drug Administration
Published: 1994-07-18

Substantially Equivalent

Madsen Electronics (Canada) , Ltd.

FDA 510(k) clearance K942749 for HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT, Substantially Equivalent on 1994-07-18. Applicant: Madsen Electronics (Canada) , Ltd.. Device class: 1.

Clearance details

Applicant: Madsen Electronics (Canada) , Ltd.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1994-06-10
Decision date: 1994-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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