MULTIFLEX TINNITUS TECHNOLOGY— 510(k) K122876

Name: FDA 510(k) clearance K122876
Creator: U.S. Food and Drug Administration
Published: 2012-10-31

Substantially Equivalent

Starkey Laboratories

FDA 510(k) clearance K122876 for MULTIFLEX TINNITUS TECHNOLOGY, Substantially Equivalent on 2012-10-31. Applicant: Starkey Laboratories. Device class: 2.

Clearance details

Applicant: Starkey Laboratories
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2012-09-19
Decision date: 2012-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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