FONIX ,MODEL 8000— 510(k) K093006

Substantially Equivalent

Frye Electronics, Inc.

FDA 510(k) clearance K093006 for FONIX ,MODEL 8000, Substantially Equivalent on 2009-12-30. 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: 2009-09-28
Decision date: 2009-12-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tigard, OR, 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.