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FDA 510(k)

DEMLAR SYS I COMPUTER BASED AUDIOMETER

K-Number: K841167 · 1984-06-27

ApplicantDemlar Medical, Inc.
Decision Date1984-06-27
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DEMLAR SYS I COMPUTER BASED AUDIOMETER 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 1984-06-27 under 510(k) number K841167. 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 DEMLAR SYS I COMPUTER BASED AUDIOMETER?

DEMLAR SYS I COMPUTER BASED AUDIOMETER is a medical device that received FDA 510(k) clearance on 1984-06-27. The listed applicant is Demlar Medical, Inc.. The 510(k) number is K841167.

When did DEMLAR SYS I COMPUTER BASED AUDIOMETER receive FDA 510(k) clearance?

DEMLAR SYS I COMPUTER BASED AUDIOMETER received FDA 510(k) clearance on 1984-06-27, under 510(k) number K841167.

Who is the listed applicant for DEMLAR SYS I COMPUTER BASED AUDIOMETER?

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 DEMLAR SYS I COMPUTER BASED AUDIOMETER?

The FDA product code for DEMLAR SYS I COMPUTER BASED AUDIOMETER is EWO.

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 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.

K803072HIGH FREQUENCY AUDIOMETER DELMAR #20-K

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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