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FDA 510(k)

CUSTOMIZED SOUND THERAPY (CST)

K-Number: K070599 · 2007-07-13

ApplicantTinnitus Otosound Products, LLC
Decision Date2007-07-13
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOMIZED SOUND THERAPY (CST) is the device name listed in this FDA 510(k) record. The listed applicant is Tinnitus Otosound Products, LLC. It received FDA 510(k) clearance on 2007-07-13 under 510(k) number K070599. 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 CUSTOMIZED SOUND THERAPY (CST)?

CUSTOMIZED SOUND THERAPY (CST) is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Tinnitus Otosound Products, LLC. The 510(k) number is K070599.

When did CUSTOMIZED SOUND THERAPY (CST) receive FDA 510(k) clearance?

CUSTOMIZED SOUND THERAPY (CST) received FDA 510(k) clearance on 2007-07-13, under 510(k) number K070599.

Who is the listed applicant for CUSTOMIZED SOUND THERAPY (CST)?

The FDA 510(k) record lists Tinnitus Otosound Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOMIZED SOUND THERAPY (CST)?

The FDA product code for CUSTOMIZED SOUND THERAPY (CST) is KLW.

Related Clinical Trials

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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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

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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