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FDA 510(k)

AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)

K-Number: K982566 · 1998-10-21

ApplicantBar - Advanced Control Systems , Ltd.
Decision Date1998-10-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) is the device name listed in this FDA 510(k) record. The listed applicant is Bar - Advanced Control Systems , Ltd.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982566. 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 AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)?

AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Bar - Advanced Control Systems , Ltd.. The 510(k) number is K982566.

When did AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) receive FDA 510(k) clearance?

AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982566.

Who is the listed applicant for AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)?

The FDA 510(k) record lists Bar - Advanced Control Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)?

The FDA product code for AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) is EWO.

Related Clinical Trials

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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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