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FDA 510(k)

AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

K-Number: K043219 · 2005-02-04

ApplicantInteracoustics AS
Decision Date2005-02-04
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics AS. It received FDA 510(k) clearance on 2005-02-04 under 510(k) number K043219. 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 AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS?

AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-02-04. The listed applicant is Interacoustics AS. The 510(k) number is K043219.

When did AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS receive FDA 510(k) clearance?

AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS received FDA 510(k) clearance on 2005-02-04, under 510(k) number K043219.

Who is the listed applicant for AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS?

The FDA 510(k) record lists Interacoustics AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS?

The FDA product code for AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Interacoustics AS 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.

K090406EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULEK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEK052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.

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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