Pseudo Isochromatic Color Blindness Test Book - 15
FDA 510(k) K873911 · Richmond Products, Inc.
510(k) numberK873911
Submission
- Device name
- Pseudo Isochromatic Color Blindness Test Book - 15
- Applicant
- Richmond Products, Inc.
Boca Raton, FL, US - Received
- September 25, 1987
- Decision date
- December 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 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 |
| 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 |
More from Visidyne Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K874252 | Kreda DiscHOQ · Traditional | 01/27/1988SE |
| K874251 | Worth 4 Dot Test Distance C/W Muscle LightHLP · Traditional | 01/11/1988SE |
| K874250 | Three Char. Test-Child & Worth 4 Dot Test Nearpt.HLP · Traditional | 01/11/1988SE |
| K873907 | Confirmation TestsHPC · Traditional | 12/29/1987SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | 12/23/1987SE |
| K873916 | 'E' Cube and 'E' PadHOX · Traditional | 12/11/1987SE |
| K873914 | Animated Fixation Toys (Distance and Nearpoint)HPL · Traditional | 12/11/1987SE |
| K873913 | Color Book Illuminator StandHJD · Traditional | 12/02/1987SE |
| K873917 | Tonometer TapesHKX · Traditional | 11/02/1987SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | 11/02/1987SE |
Questions and answers
When was Pseudo Isochromatic Color Blindness Test Book - 15 cleared by the FDA?
Pseudo Isochromatic Color Blindness Test Book - 15 (K873911) received a 510(k) decision of Substantially Equivalent on December 2, 1987, 68 days after the submission was received.
What is the product code of K873911?
The FDA product code is HIT – Tester, Color Vision, a Class I (low risk) device regulated under 21 CFR 886.1170.