SMART-SCREENER (AUDITORY)— 510(k) K925648

Name: FDA 510(k) clearance K925648
Creator: U.S. Food and Drug Administration
Published: 1993-05-11

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K925648 for SMART-SCREENER (AUDITORY), Substantially Equivalent on 1993-05-11. Applicant: Intelligent Hearing Systems. Device class: 2.

Clearance details

Applicant: Intelligent Hearing Systems
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 1992-11-09
Decision date: 1993-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North 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.