Chromops FM-100 Color Vision Tester

FDA 510(k) K810700 · Visidyne Corp.

Substantially Equivalent

510(k) numberK810700

Submission

Device name
Chromops FM-100 Color Vision Tester
Applicant
Visidyne Corp.
Mchenry, IL, US
Received
March 16, 1981
Decision date
April 10, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HIT – Tester, Color Vision
Device class
Class I (low risk)
Regulation
21 CFR 886.1170
Specialty
Ophthalmic

Other 510(k)s with product code HIT

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K903001Slimcath (TM)HIT · Traditional Gynopharma, Inc.06/25/1991SE
K875026Anomaloscope Plate Test - 5 [APT-5]HIT · Traditional Lkc Technologies, Inc.02/05/1988SE
K873908H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional Richmond Products, Inc.12/23/1987SE
K873911Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional Richmond Products, Inc.12/02/1987SE
K844694Titmus Vision Tester IIHIT · Traditional Titmus Optical, Inc.01/22/1985SE
K844365Color Vision TestersHIT · Traditional Luneau Laboratories01/02/1985SE
K832843Oscar Colour Vision TesterHIT · Traditional Keeler Instruments, Inc.01/04/1984SE
K831074Oscar Color Vision TesterHIT · Traditional Carl Zeiss, Inc.04/28/1983SE

More from Carl Zeiss, Inc.

510(k)DeviceDecision
K811316Triscan, Models 38,40,41,43 & 45IYO · Traditional 07/02/1981SE
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Questions and answers

When was Chromops FM-100 Color Vision Tester cleared by the FDA?

Chromops FM-100 Color Vision Tester (K810700) received a 510(k) decision of Substantially Equivalent on April 10, 1981, 25 days after the submission was received.

What is the product code of K810700?

The FDA product code is HIT – Tester, Color Vision, a Class I (low risk) device regulated under 21 CFR 886.1170.