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FDA 510(k)

SIBELMED AC50D

K-Number: K973377 · 1998-03-10

ApplicantTrutone
Decision Date1998-03-10
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SIBELMED AC50D is the device name listed in this FDA 510(k) record. The listed applicant is Trutone. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K973377. 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 SIBELMED AC50D?

SIBELMED AC50D is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Trutone. The 510(k) number is K973377.

When did SIBELMED AC50D receive FDA 510(k) clearance?

SIBELMED AC50D received FDA 510(k) clearance on 1998-03-10, under 510(k) number K973377.

Who is the listed applicant for SIBELMED AC50D?

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

What is the FDA product code for SIBELMED AC50D?

The FDA product code for SIBELMED AC50D is EWO.

Related Clinical Trials

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Other records listing Trutone 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.

K972550AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGCK972552AUDIFON H20 PC/AUDIFON H32 PPK972542JAZZ PP AGC-O, JAZZ PPK972543TWIST PPAGC-1, TWIST PP

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

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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