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FDA 510(k)

CAPELLA COCHLEAR EMISSIONS ANALYZER

K-Number: K983851 · 1999-01-28

ApplicantMadsen Electronics, Inc.
Decision Date1999-01-28
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CAPELLA COCHLEAR EMISSIONS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Madsen Electronics, Inc.. It received FDA 510(k) clearance on 1999-01-28 under 510(k) number K983851. 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 CAPELLA COCHLEAR EMISSIONS ANALYZER?

CAPELLA COCHLEAR EMISSIONS ANALYZER is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Madsen Electronics, Inc.. The 510(k) number is K983851.

When did CAPELLA COCHLEAR EMISSIONS ANALYZER receive FDA 510(k) clearance?

CAPELLA COCHLEAR EMISSIONS ANALYZER received FDA 510(k) clearance on 1999-01-28, under 510(k) number K983851.

Who is the listed applicant for CAPELLA COCHLEAR EMISSIONS ANALYZER?

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

What is the FDA product code for CAPELLA COCHLEAR EMISSIONS ANALYZER?

The FDA product code for CAPELLA COCHLEAR EMISSIONS ANALYZER is EWO.

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Other records listing Madsen Electronics, 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.

K002200CAPELLAK945199RH2000 REAL EAR MEASUREMENT SYSTEMK945032VOYAGER 522

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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