Miller/Nadler Glare Tester

FDA 510(k) K832762 · Titmus Optical, Inc.

Substantially Equivalent

510(k) numberK832762

Submission

Device name
Miller/Nadler Glare Tester
Applicant
Titmus Optical, Inc.
Walker, MI, US
Received
August 16, 1983
Decision date
September 29, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HLX – Photostimulator, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1630
Specialty
Ophthalmic

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K853812Photron Neurovisual Stimulator(Modification)HLX · Traditional Biosan Laboratories, Inc.11/01/1985SE
K833446Downing Spectral IlluminatorHLX · Traditional Vision Health Technology03/12/1984SE
K831231LED GogglesHLX · Traditional Cadwell Laboratories, Inc.05/16/1983SE
K830770Contrast Sensitivity EquipmentHLX · Traditional Cadwell Laboratories, Inc.04/28/1983SE

More from Cadwell Laboratories, Inc.

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K844694Titmus Vision Tester IIHIT · Traditional 01/22/1985SE
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Questions and answers

When was Miller/Nadler Glare Tester cleared by the FDA?

Miller/Nadler Glare Tester (K832762) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 44 days after the submission was received.

What is the product code of K832762?

The FDA product code is HLX – Photostimulator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1630.