TINNITUS PHASE-OUT— 510(k) K061111

Substantially Equivalent

Tinnitus Control, Inc.

FDA 510(k) clearance K061111 for TINNITUS PHASE-OUT, Substantially Equivalent on 2006-05-16. Applicant: Tinnitus Control, Inc.. Device class: 2.

Clearance details

Applicant: Tinnitus Control, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2006-04-21
Decision date: 2006-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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