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FDA 510(k)

ATTENU-CHEK

K-Number: K802350 · 1980-10-23

ApplicantHear Co., Inc.
Decision Date1980-10-23
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ATTENU-CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Hear Co., Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802350. 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 ATTENU-CHEK?

ATTENU-CHEK is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Hear Co., Inc.. The 510(k) number is K802350.

When did ATTENU-CHEK receive FDA 510(k) clearance?

ATTENU-CHEK received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802350.

Who is the listed applicant for ATTENU-CHEK?

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

What is the FDA product code for ATTENU-CHEK?

The FDA product code for ATTENU-CHEK 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 Hear Co., 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.

K831129HEARCO C

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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