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FDA 510(k)

VIVOSONIC NEUROSCREEN

K-Number: K080060 · 2008-04-04

ApplicantVivosonic, Inc.
Decision Date2008-04-04
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VIVOSONIC NEUROSCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Vivosonic, Inc.. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K080060. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVOSONIC NEUROSCREEN?

VIVOSONIC NEUROSCREEN is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is Vivosonic, Inc.. The 510(k) number is K080060.

When did VIVOSONIC NEUROSCREEN receive FDA 510(k) clearance?

VIVOSONIC NEUROSCREEN received FDA 510(k) clearance on 2008-04-04, under 510(k) number K080060.

Who is the listed applicant for VIVOSONIC NEUROSCREEN?

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 VIVOSONIC NEUROSCREEN?

The FDA product code for VIVOSONIC NEUROSCREEN is GWJ.

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)K043396INTEGRITY, MODEL V500K033108VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETERK003364VIVO 200 DPS VIVOSCAN

Related Devices (Code: GWJ)

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)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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.

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