TINNITUS SOUNDSUPPORT

Masker, Tinnitus

OTICON A/S

The following data is part of a premarket notification filed by Oticon A/s with the FDA for Tinnitus Soundsupport.

Pre-market Notification Details

• Device ID: K133308
• 510k Number: K133308
• Device Name: TINNITUS SOUNDSUPPORT
• Classification: Masker, Tinnitus
• Applicant: OTICON A/S KONGEBAKKEN 9 Smorum, DK Dk-2765
• Contact: Soren Juel Witt
• Correspondent: Soren Juel Witt; OTICON A/S KONGEBAKKEN 9 Smorum, DK Dk-2765
• Product Code: KLW
• CFR Regulation Number: 874.3400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-28
• Decision Date: 2014-03-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05707131329868	K133308	000
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