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FDA 510(k)

TINNITUS RESEARCH AUDIOMETER

K-Number: K802560 · 1980-11-12

ApplicantStarkey Laboratories, Inc.
Decision Date1980-11-12
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TINNITUS RESEARCH AUDIOMETER 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 1980-11-12 under 510(k) number K802560. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINNITUS RESEARCH AUDIOMETER?

TINNITUS RESEARCH AUDIOMETER is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K802560.

When did TINNITUS RESEARCH AUDIOMETER receive FDA 510(k) clearance?

TINNITUS RESEARCH AUDIOMETER received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802560.

Who is the listed applicant for TINNITUS RESEARCH AUDIOMETER?

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 RESEARCH AUDIOMETER?

The FDA product code for TINNITUS RESEARCH AUDIOMETER is EWO.

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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: EWO)

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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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