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FDA 510(k)

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM

K-Number: K111293 · 2011-08-24

ApplicantSoundcure, Inc.
Decision Date2011-08-24
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Soundcure, Inc.. It received FDA 510(k) clearance on 2011-08-24 under 510(k) number K111293. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM?

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-24. The listed applicant is Soundcure, Inc.. The 510(k) number is K111293.

When did SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM receive FDA 510(k) clearance?

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM received FDA 510(k) clearance on 2011-08-24, under 510(k) number K111293.

Who is the listed applicant for SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM?

The FDA 510(k) record lists Soundcure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM?

The FDA product code for SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM is KLW.

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Related Devices (Code: KLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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