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FDA 510(k)

UNITRON TINNITUS MASKER FEATURE

K-Number: K130494 · 2013-05-07

ApplicantUnitron Hearing
Decision Date2013-05-07
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UNITRON TINNITUS MASKER FEATURE is the device name listed in this FDA 510(k) record. The listed applicant is Unitron Hearing. It received FDA 510(k) clearance on 2013-05-07 under 510(k) number K130494. 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 UNITRON TINNITUS MASKER FEATURE?

UNITRON TINNITUS MASKER FEATURE is a medical device that received FDA 510(k) clearance on 2013-05-07. The listed applicant is Unitron Hearing. The 510(k) number is K130494.

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

UNITRON TINNITUS MASKER FEATURE received FDA 510(k) clearance on 2013-05-07, under 510(k) number K130494.

Who is the listed applicant for UNITRON TINNITUS MASKER FEATURE?

The FDA 510(k) record lists Unitron Hearing as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNITRON TINNITUS MASKER FEATURE?

The FDA product code for UNITRON TINNITUS MASKER FEATURE 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

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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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