HEARLAB ACA— 510(k) K123701

Substantially Equivalent

Frye Electronics, Inc.

FDA 510(k) clearance K123701 for HEARLAB ACA, Substantially Equivalent on 2013-04-05. Applicant: Frye Electronics, Inc..

Clearance details

Applicant: Frye Electronics, Inc.
Product code: Code GWJ
Advisory panel: Neurology
Date received: 2012-12-03
Decision date: 2013-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tigard, OR, US

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