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FDA 510(k)

DIGITAL TINNITUS MASKING SYSTEM

K-Number: K974501 · 1998-01-20

ApplicantPetroff Audio Technologies
Decision Date1998-01-20
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DIGITAL TINNITUS MASKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Petroff Audio Technologies. It received FDA 510(k) clearance on 1998-01-20 under 510(k) number K974501. 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 DIGITAL TINNITUS MASKING SYSTEM?

DIGITAL TINNITUS MASKING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-20. The listed applicant is Petroff Audio Technologies. The 510(k) number is K974501.

When did DIGITAL TINNITUS MASKING SYSTEM receive FDA 510(k) clearance?

DIGITAL TINNITUS MASKING SYSTEM received FDA 510(k) clearance on 1998-01-20, under 510(k) number K974501.

Who is the listed applicant for DIGITAL TINNITUS MASKING SYSTEM?

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

What is the FDA product code for DIGITAL TINNITUS MASKING SYSTEM?

The FDA product code for DIGITAL TINNITUS MASKING SYSTEM 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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