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FDA 510(k)

HIGH FREQUENCY AUDIOMETER DELMAR #20-K

K-Number: K803072 · 1980-12-30

ApplicantDemlar Medical, Inc.
Decision Date1980-12-30
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HIGH FREQUENCY AUDIOMETER DELMAR #20-K is the device name listed in this FDA 510(k) record. The listed applicant is Demlar Medical, Inc.. It received FDA 510(k) clearance on 1980-12-30 under 510(k) number K803072. 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 HIGH FREQUENCY AUDIOMETER DELMAR #20-K?

HIGH FREQUENCY AUDIOMETER DELMAR #20-K is a medical device that received FDA 510(k) clearance on 1980-12-30. The listed applicant is Demlar Medical, Inc.. The 510(k) number is K803072.

When did HIGH FREQUENCY AUDIOMETER DELMAR #20-K receive FDA 510(k) clearance?

HIGH FREQUENCY AUDIOMETER DELMAR #20-K received FDA 510(k) clearance on 1980-12-30, under 510(k) number K803072.

Who is the listed applicant for HIGH FREQUENCY AUDIOMETER DELMAR #20-K?

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

What is the FDA product code for HIGH FREQUENCY AUDIOMETER DELMAR #20-K?

The FDA product code for HIGH FREQUENCY AUDIOMETER DELMAR #20-K is EWO.

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Other records listing Demlar Medical, 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.

K841167DEMLAR SYS I COMPUTER BASED AUDIOMETER

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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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