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FDA 510(k)

TINNITUS MASKER

K-Number: K781798 · 1978-11-03

ApplicantStarkey Laboratories, Inc.
Decision Date1978-11-03
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TINNITUS MASKER is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781798. 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 MASKER?

TINNITUS MASKER is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K781798.

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

TINNITUS MASKER received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781798.

Who is the listed applicant for TINNITUS MASKER?

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

What is the FDA product code for TINNITUS MASKER?

The FDA product code for TINNITUS MASKER is KLW.

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Other records listing Starkey Laboratories, 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.

K201370Multiflex Tinnitus TechnologyK030180CRESCENT TINNITUS RETAINING SOUND GENERATORK970952PRECISE IMPRESSION KITK964245PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITSK964340PORTAREM-3000, PFS-6000K964216STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER

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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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