FONIX, MODEL 7000— 510(k) K022510

Substantially Equivalent

Frye Electronics, Inc.

FDA 510(k) clearance K022510 for FONIX, MODEL 7000, Substantially Equivalent on 2002-08-27. 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: 2002-07-30
Decision date: 2002-08-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tigard, OR, US

Download summary PDF View on FDA.gov ↗

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