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FDA 510(k)

RH2000 REAL EAR MEASUREMENT SYSTEM

K-Number: K945199 · 1995-04-11

ApplicantMadsen Electronics, Inc.
Decision Date1995-04-11
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RH2000 REAL EAR MEASUREMENT SYSTEM 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 1995-04-11 under 510(k) number K945199. 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 RH2000 REAL EAR MEASUREMENT SYSTEM?

RH2000 REAL EAR MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is Madsen Electronics, Inc.. The 510(k) number is K945199.

When did RH2000 REAL EAR MEASUREMENT SYSTEM receive FDA 510(k) clearance?

RH2000 REAL EAR MEASUREMENT SYSTEM received FDA 510(k) clearance on 1995-04-11, under 510(k) number K945199.

Who is the listed applicant for RH2000 REAL EAR MEASUREMENT SYSTEM?

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 RH2000 REAL EAR MEASUREMENT SYSTEM?

The FDA product code for RH2000 REAL EAR MEASUREMENT SYSTEM 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 ANALYZERK945032VOYAGER 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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