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FDA 510(k)

VIVO 200 DPS VIVOSCAN

K-Number: K003364 · 2001-07-18

ApplicantVivosonic, Inc.
Decision Date2001-07-18
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VIVO 200 DPS VIVOSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Vivosonic, Inc.. It received FDA 510(k) clearance on 2001-07-18 under 510(k) number K003364. 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 VIVO 200 DPS VIVOSCAN?

VIVO 200 DPS VIVOSCAN is a medical device that received FDA 510(k) clearance on 2001-07-18. The listed applicant is Vivosonic, Inc.. The 510(k) number is K003364.

When did VIVO 200 DPS VIVOSCAN receive FDA 510(k) clearance?

VIVO 200 DPS VIVOSCAN received FDA 510(k) clearance on 2001-07-18, under 510(k) number K003364.

Who is the listed applicant for VIVO 200 DPS VIVOSCAN?

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

What is the FDA product code for VIVO 200 DPS VIVOSCAN?

The FDA product code for VIVO 200 DPS VIVOSCAN 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 Vivosonic, 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.

K242954Integrity V500 (Integrity, Integrity with VEMP)K080060VIVOSONIC NEUROSCREENK043396INTEGRITY, MODEL V500K033108VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

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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