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FDA 510(k)

MICRO MASKER

K-Number: K924991 · 1993-06-14

ApplicantAssociated Hearing Instruments
Decision Date1993-06-14
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICRO MASKER is the device name listed in this FDA 510(k) record. The listed applicant is Associated Hearing Instruments. It received FDA 510(k) clearance on 1993-06-14 under 510(k) number K924991. 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 MICRO MASKER?

MICRO MASKER is a medical device that received FDA 510(k) clearance on 1993-06-14. The listed applicant is Associated Hearing Instruments. The 510(k) number is K924991.

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

MICRO MASKER received FDA 510(k) clearance on 1993-06-14, under 510(k) number K924991.

Who is the listed applicant for MICRO MASKER?

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

What is the FDA product code for MICRO MASKER?

The FDA product code for MICRO MASKER is KLW.

Related Clinical Trials

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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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