Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

K-Number: K033108 · 2003-10-27

ApplicantVivosonic, Inc.
Decision Date2003-10-27
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Vivosonic, Inc.. It received FDA 510(k) clearance on 2003-10-27 under 510(k) number K033108. 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 VERSION 2.0 OAE AUDIOMETER?

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER is a medical device that received FDA 510(k) clearance on 2003-10-27. The listed applicant is Vivosonic, Inc.. The 510(k) number is K033108.

When did VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER receive FDA 510(k) clearance?

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER received FDA 510(k) clearance on 2003-10-27, under 510(k) number K033108.

Who is the listed applicant for VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER?

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 VERSION 2.0 OAE AUDIOMETER?

The FDA product code for VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER 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 V500K003364VIVO 200 DPS VIVOSCAN

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑