SMARTSCREENER-PLUS2— 510(k) K090579

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K090579 for SMARTSCREENER-PLUS2, Substantially Equivalent on 2009-07-07. Applicant: Intelligent Hearing Systems.

Clearance details

Applicant: Intelligent Hearing Systems
Product code: Code GWJ
Advisory panel: Neurology
Date received: 2009-03-03
Decision date: 2009-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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