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FDA 510(k)

MICROMATE 304

K-Number: K896401 · 1990-03-27

ApplicantMadsen North America, Inc.
Decision Date1990-03-27
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICROMATE 304 is the device name listed in this FDA 510(k) record. The listed applicant is Madsen North America, Inc.. It received FDA 510(k) clearance on 1990-03-27 under 510(k) number K896401. 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 MICROMATE 304?

MICROMATE 304 is a medical device that received FDA 510(k) clearance on 1990-03-27. The listed applicant is Madsen North America, Inc.. The 510(k) number is K896401.

When did MICROMATE 304 receive FDA 510(k) clearance?

MICROMATE 304 received FDA 510(k) clearance on 1990-03-27, under 510(k) number K896401.

Who is the listed applicant for MICROMATE 304?

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

What is the FDA product code for MICROMATE 304?

The FDA product code for MICROMATE 304 is EWO.

Related Clinical Trials

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.

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Other records listing Madsen North America, 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.

K897143VERA 103K896710MIDIMATE 622

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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