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FDA 510(k)

VISUAL PATTERN REVERSAL GEN. & PHOTIC S.

K-Number: K810481 · 1981-03-11

ApplicantAmplaid USA, Inc.
Decision Date1981-03-11
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VISUAL PATTERN REVERSAL GEN. & PHOTIC S. is the device name listed in this FDA 510(k) record. The listed applicant is Amplaid USA, Inc.. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810481. 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 VISUAL PATTERN REVERSAL GEN. & PHOTIC S.?

VISUAL PATTERN REVERSAL GEN. & PHOTIC S. is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Amplaid USA, Inc.. The 510(k) number is K810481.

When did VISUAL PATTERN REVERSAL GEN. & PHOTIC S. receive FDA 510(k) clearance?

VISUAL PATTERN REVERSAL GEN. & PHOTIC S. received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810481.

Who is the listed applicant for VISUAL PATTERN REVERSAL GEN. & PHOTIC S.?

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

What is the FDA product code for VISUAL PATTERN REVERSAL GEN. & PHOTIC S.?

The FDA product code for VISUAL PATTERN REVERSAL GEN. & PHOTIC S. is GWE.

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Other records listing Amplaid USA, 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.

K861014AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)K832510EVOKED POTENTIALS SYSTEM MK10K810473MK6 ERA SYSTEMK810482SOMATOSENSORY STIMULATORK802963101, 151, 161 PORTABLE AUDIOMETERSK802097SELF-RECORDING ADMITTANCE METER 709

View all 8 devices →

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

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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