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FDA 510(k)

MIDIMATE 622

K-Number: K896710 · 1990-04-13

ApplicantMadsen North America, Inc.
Decision Date1990-04-13
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MIDIMATE 622 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 1990-04-13 under 510(k) number K896710. 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 MIDIMATE 622?

MIDIMATE 622 is a medical device that received FDA 510(k) clearance on 1990-04-13. The listed applicant is Madsen North America, Inc.. The 510(k) number is K896710.

When did MIDIMATE 622 receive FDA 510(k) clearance?

MIDIMATE 622 received FDA 510(k) clearance on 1990-04-13, under 510(k) number K896710.

Who is the listed applicant for MIDIMATE 622?

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 MIDIMATE 622?

The FDA product code for MIDIMATE 622 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 103K896401MICROMATE 304

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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