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FDA 510(k)

T-570 TINNITUS MASKER

K-Number: K800701 · 1980-04-10

ApplicantAudiotrone
Decision Date1980-04-10
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

T-570 TINNITUS MASKER is the device name listed in this FDA 510(k) record. The listed applicant is Audiotrone. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800701. 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 T-570 TINNITUS MASKER?

T-570 TINNITUS MASKER is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Audiotrone. The 510(k) number is K800701.

When did T-570 TINNITUS MASKER receive FDA 510(k) clearance?

T-570 TINNITUS MASKER received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800701.

Who is the listed applicant for T-570 TINNITUS MASKER?

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

What is the FDA product code for T-570 TINNITUS MASKER?

The FDA product code for T-570 TINNITUS MASKER 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 Audiotrone 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.

K800702TA-641 TINNITUS INSTRUMENT

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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