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FDA 510(k)

DIOPSYS NOVA VEP VISION TESTING SYSTEM

K-Number: K101763 · 2011-05-09

ApplicantDiopsys, Inc.
Decision Date2011-05-09
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DIOPSYS NOVA VEP VISION TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diopsys, Inc.. It received FDA 510(k) clearance on 2011-05-09 under 510(k) number K101763. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIOPSYS NOVA VEP VISION TESTING SYSTEM?

DIOPSYS NOVA VEP VISION TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-09. The listed applicant is Diopsys, Inc.. The 510(k) number is K101763.

When did DIOPSYS NOVA VEP VISION TESTING SYSTEM receive FDA 510(k) clearance?

DIOPSYS NOVA VEP VISION TESTING SYSTEM received FDA 510(k) clearance on 2011-05-09, under 510(k) number K101763.

Who is the listed applicant for DIOPSYS NOVA VEP VISION TESTING SYSTEM?

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

What is the FDA product code for DIOPSYS NOVA VEP VISION TESTING SYSTEM?

The FDA product code for DIOPSYS NOVA VEP VISION TESTING SYSTEM is GWE.

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 Diopsys, 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.

K043491ENFANTTM

Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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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