Tester, Color Vision
FDA product code HIT · Class I (low risk) · 21 CFR 886.1170 · Ophthalmic
9510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K903001 | Slimcath (TM)HIT · Traditional | Gynopharma, Inc. | 06/25/1991SE |
| K875026 | Anomaloscope Plate Test - 5 [APT-5]HIT · Traditional | Lkc Technologies, Inc. | 02/05/1988SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | Richmond Products, Inc. | 12/23/1987SE |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | Richmond Products, Inc. | 12/02/1987SE |
| K844694 | Titmus Vision Tester IIHIT · Traditional | Titmus Optical, Inc. | 01/22/1985SE |
| K844365 | Color Vision TestersHIT · Traditional | Luneau Laboratories | 01/02/1985SE |
| K832843 | Oscar Colour Vision TesterHIT · Traditional | Keeler Instruments, Inc. | 01/04/1984SE |
| K831074 | Oscar Color Vision TesterHIT · Traditional | Carl Zeiss, Inc. | 04/28/1983SE |
| K810700 | Chromops FM-100 Color Vision TesterHIT · Traditional | Visidyne Corp. | 04/10/1981SE |