FONIX TYPE 5100 HEARING AID ANALYZER— 510(k) K801905

Name: FDA 510(k) clearance K801905
Creator: U.S. Food and Drug Administration
Published: 1980-08-27

Substantially Equivalent

Frye Electronics, Inc.

FDA 510(k) clearance K801905 for FONIX TYPE 5100 HEARING AID ANALYZER, Substantially Equivalent on 1980-08-27. Applicant: Frye Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Frye Electronics, Inc.
Product code: Code ETW
Device class: Class 2
Regulation: 21 CFR 874.3310
Advisory panel: Ear, Nose, Throat
Date received: 1980-08-11
Decision date: 1980-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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