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FDA 510(k)

V100 VISUALLY EVOKED POTENTIAL MONITOR

K-Number: K860910 · 1986-12-18

ApplicantNew Potentials, Inc.
Decision Date1986-12-18
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

V100 VISUALLY EVOKED POTENTIAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is New Potentials, Inc.. It received FDA 510(k) clearance on 1986-12-18 under 510(k) number K860910. 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 V100 VISUALLY EVOKED POTENTIAL MONITOR?

V100 VISUALLY EVOKED POTENTIAL MONITOR is a medical device that received FDA 510(k) clearance on 1986-12-18. The listed applicant is New Potentials, Inc.. The 510(k) number is K860910.

When did V100 VISUALLY EVOKED POTENTIAL MONITOR receive FDA 510(k) clearance?

V100 VISUALLY EVOKED POTENTIAL MONITOR received FDA 510(k) clearance on 1986-12-18, under 510(k) number K860910.

Who is the listed applicant for V100 VISUALLY EVOKED POTENTIAL MONITOR?

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

What is the FDA product code for V100 VISUALLY EVOKED POTENTIAL MONITOR?

The FDA product code for V100 VISUALLY EVOKED POTENTIAL MONITOR is GWE.

Related Clinical Trials

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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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