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FDA 510(k)

TINNITUS RX

K-Number: K031624 · 2003-07-24

ApplicantTinnitus Control, Inc.
Decision Date2003-07-24
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TINNITUS RX 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 2003-07-24 under 510(k) number K031624. 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 RX?

TINNITUS RX is a medical device that received FDA 510(k) clearance on 2003-07-24. The listed applicant is Tinnitus Control, Inc.. The 510(k) number is K031624.

When did TINNITUS RX receive FDA 510(k) clearance?

TINNITUS RX received FDA 510(k) clearance on 2003-07-24, under 510(k) number K031624.

Who is the listed applicant for TINNITUS RX?

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 RX?

The FDA product code for TINNITUS RX 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K061111TINNITUS PHASE-OUT

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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