WICK ELECTRODE, MODEL M019260— 510(k) K063402

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K063402 for WICK ELECTRODE, MODEL M019260, Substantially Equivalent on 2006-12-11. Applicant: Intelligent Hearing Systems. Device class: 2.

Clearance details

Applicant
Intelligent Hearing Systems
Product code
Code GXY
Device class
Class 2
Regulation
21 CFR 882.1320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
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