FDA 510(k)

MODEL S10VS VISUAL STIMULATOR

K-Number: K812061 · 1981-08-20

Decision Date1981-08-20

Product CodeGWE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MODEL S10VS VISUAL STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Grass Instrument Co.. It received FDA 510(k) clearance on 1981-08-20 under 510(k) number K812061. 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 MODEL S10VS VISUAL STIMULATOR?

MODEL S10VS VISUAL STIMULATOR is a medical device that received FDA 510(k) clearance on 1981-08-20. The listed applicant is Grass Instrument Co.. The 510(k) number is K812061.

When did MODEL S10VS VISUAL STIMULATOR receive FDA 510(k) clearance?

MODEL S10VS VISUAL STIMULATOR received FDA 510(k) clearance on 1981-08-20, under 510(k) number K812061.

Who is the listed applicant for MODEL S10VS VISUAL STIMULATOR?

The FDA 510(k) record lists Grass Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL S10VS VISUAL STIMULATOR?

The FDA product code for MODEL S10VS VISUAL STIMULATOR is GWE.

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Other records listing Grass Instrument Co. as applicant

K021807GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM K994142GRASS TS3201/6401 EEG AMPLIFIER SYSTEM K844216GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR K810539MODEL S10CTCM AUDITORY STIMULATOR K771742EVOKED RESPONSE SYS., MODEL 10

Related Devices (Code: GWE)

K221471E3 and ProfileDiagnosys, LLC K212936Vision Monitor- MonCvONEMetrovision K211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovision K200705Nurochek 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.