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FDA 510(k)

TINNITUS PHASE-OUT

K-Number: K061111 · 2006-05-16

ApplicantTinnitus Control, Inc.
Decision Date2006-05-16
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TINNITUS PHASE-OUT is the device name listed in this FDA 510(k) record. The listed applicant is Tinnitus Control, Inc.. It received FDA 510(k) clearance on 2006-05-16 under 510(k) number K061111. 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 TINNITUS PHASE-OUT?

TINNITUS PHASE-OUT is a medical device that received FDA 510(k) clearance on 2006-05-16. The listed applicant is Tinnitus Control, Inc.. The 510(k) number is K061111.

When did TINNITUS PHASE-OUT receive FDA 510(k) clearance?

TINNITUS PHASE-OUT received FDA 510(k) clearance on 2006-05-16, under 510(k) number K061111.

Who is the listed applicant for TINNITUS PHASE-OUT?

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

What is the FDA product code for TINNITUS PHASE-OUT?

The FDA product code for TINNITUS PHASE-OUT is KLW.

Related Clinical Trials

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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Other records listing Tinnitus Control, Inc. as applicant

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.

K031624TINNITUS RX

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

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

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