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FDA 510(k)

INTEGRITY, MODEL V500

K-Number: K043396 · 2005-01-24

ApplicantVivosonic, Inc.
Decision Date2005-01-24
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTEGRITY, MODEL V500 is the device name listed in this FDA 510(k) record. The listed applicant is Vivosonic, Inc.. It received FDA 510(k) clearance on 2005-01-24 under 510(k) number K043396. 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 INTEGRITY, MODEL V500?

INTEGRITY, MODEL V500 is a medical device that received FDA 510(k) clearance on 2005-01-24. The listed applicant is Vivosonic, Inc.. The 510(k) number is K043396.

When did INTEGRITY, MODEL V500 receive FDA 510(k) clearance?

INTEGRITY, MODEL V500 received FDA 510(k) clearance on 2005-01-24, under 510(k) number K043396.

Who is the listed applicant for INTEGRITY, MODEL V500?

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 INTEGRITY, MODEL V500?

The FDA product code for INTEGRITY, MODEL V500 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.

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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 NEUROSCREENK033108VIVO 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

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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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