Anomaloscope Quadrant TEST-6

FDA 510(k) K913962 · Lkc Technologies, Inc.

Substantially Equivalent

510(k) numberK913962

Submission

Device name
Anomaloscope Quadrant TEST-6
Applicant
Lkc Technologies, Inc.
Gaithersburg, MD, US
Received
September 5, 1991
Decision date
October 23, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HIW – Anomaloscope
Device class
Class I (low risk)
Regulation
21 CFR 886.1070
Specialty
Ophthalmic

Other 510(k)s with product code HIW

510(k)DeviceApplicantDecision
K930575Kamppeter AnomaloscopeHIW · Traditional Bova Intl.02/25/1994SE
K860174Gunkel Chromagraph Color Vision TesterHIW · Traditional Chromagraphics, Inc.04/04/1986SE

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K914163Scoptopic Sensitivity TEST-1[SST-1]HLX · Traditional 10/25/1991SE
K875026Anomaloscope Plate Test - 5 [APT-5]HIT · Traditional 02/05/1988SE
K874336Pattern Discrimination PerimeterHPT · Traditional 01/12/1988SE
K820414Universal Testing & Analysis SystemsGWF · Traditional 03/04/1982SE
K790109Telemetry, BiomedicalDRG · Traditional 03/16/1979SE
K760199ElectroretinographHLZ · Traditional 08/04/1976SE

Questions and answers

When was Anomaloscope Quadrant TEST-6 cleared by the FDA?

Anomaloscope Quadrant TEST-6 (K913962) received a 510(k) decision of Substantially Equivalent on October 23, 1991, 48 days after the submission was received.

What is the product code of K913962?

The FDA product code is HIW – Anomaloscope, a Class I (low risk) device regulated under 21 CFR 886.1070.