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FDA 510(k)

VOYAGER 522

K-Number: K945032 · 1995-02-02

ApplicantMadsen Electronics, Inc.
Decision Date1995-02-02
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOYAGER 522 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 1995-02-02 under 510(k) number K945032. 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 VOYAGER 522?

VOYAGER 522 is a medical device that received FDA 510(k) clearance on 1995-02-02. The listed applicant is Madsen Electronics, Inc.. The 510(k) number is K945032.

When did VOYAGER 522 receive FDA 510(k) clearance?

VOYAGER 522 received FDA 510(k) clearance on 1995-02-02, under 510(k) number K945032.

Who is the listed applicant for VOYAGER 522?

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 VOYAGER 522?

The FDA product code for VOYAGER 522 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.

K002200CAPELLAK983851CAPELLA COCHLEAR EMISSIONS ANALYZERK945199RH2000 REAL EAR MEASUREMENT SYSTEM

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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