TINNITUS SOUNDSUPPORT— 510(k) K133308

Substantially Equivalent

Oticon A/S

FDA 510(k) clearance K133308 for TINNITUS SOUNDSUPPORT, Substantially Equivalent on 2014-03-18. Applicant: Oticon A/S. Device class: 2.

Clearance details

Applicant: Oticon A/S
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2013-10-28
Decision date: 2014-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smorum, DK

Download summary PDF View on FDA.gov ↗

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