OPTI-AMP DC-POWERED— 510(k) K052060

Name: FDA 510(k) clearance K052060
Creator: U.S. Food and Drug Administration
Published: 2005-08-31

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K052060 for OPTI-AMP DC-POWERED, Substantially Equivalent on 2005-08-31. Applicant: Intelligent Hearing Systems. Device class: 2.

Clearance details

Applicant: Intelligent Hearing Systems
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2005-07-29
Decision date: 2005-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, 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.