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FDA 510(k)

NEUROMONICS TINNITUS TREATMENT

K-Number: K043274 · 2005-01-28

ApplicantNeuromonics Pty, Ltd.
Decision Date2005-01-28
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NEUROMONICS TINNITUS TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Neuromonics Pty, Ltd.. It received FDA 510(k) clearance on 2005-01-28 under 510(k) number K043274. 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 NEUROMONICS TINNITUS TREATMENT?

NEUROMONICS TINNITUS TREATMENT is a medical device that received FDA 510(k) clearance on 2005-01-28. The listed applicant is Neuromonics Pty, Ltd.. The 510(k) number is K043274.

When did NEUROMONICS TINNITUS TREATMENT receive FDA 510(k) clearance?

NEUROMONICS TINNITUS TREATMENT received FDA 510(k) clearance on 2005-01-28, under 510(k) number K043274.

Who is the listed applicant for NEUROMONICS TINNITUS TREATMENT?

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

What is the FDA product code for NEUROMONICS TINNITUS TREATMENT?

The FDA product code for NEUROMONICS TINNITUS TREATMENT 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.

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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