NEUROMONICS TINNITUS TREATMENT— 510(k) K043274

Name: FDA 510(k) clearance K043274
Creator: U.S. Food and Drug Administration
Published: 2005-01-28

Substantially Equivalent

Neuromonics Pty, Ltd.

FDA 510(k) clearance K043274 for NEUROMONICS TINNITUS TREATMENT, Substantially Equivalent on 2005-01-28. Applicant: Neuromonics Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Neuromonics Pty, Ltd.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2004-11-26
Decision date: 2005-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatswood, AU

Download summary PDF View on FDA.gov ↗

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