OPTI-AMP— 510(k) K914876

Substantially Equivalent

Intelligent Hearing Systems

FDA 510(k) clearance K914876 for OPTI-AMP, Substantially Equivalent on 1992-01-10. 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: 1991-10-29
Decision date: 1992-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K063402 — WICK ELECTRODE, MODEL M0192602006-12-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.