SMART USBLITE, MODEL M011120— 510(k) K061443

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K061443 for SMART USBLITE, MODEL M011120, Substantially Equivalent on 2006-06-23. Applicant: Intelligent Hearing Systems.

Clearance details

Applicant
Intelligent Hearing Systems
Product code
Code GWJ
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Miami, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.