Titmus Vision Tester II
FDA 510(k) K844694 · Titmus Optical, Inc.
510(k) numberK844694
Submission
- Device name
- Titmus Vision Tester II
- Applicant
- Titmus Optical, Inc.
Petersburg, VA, US - Received
- December 3, 1984
- Decision date
- January 22, 1985
- 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 |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | Richmond Products, Inc. | 12/02/1987SE |
| 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 |
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Questions and answers
When was Titmus Vision Tester II cleared by the FDA?
Titmus Vision Tester II (K844694) received a 510(k) decision of Substantially Equivalent on January 22, 1985, 50 days after the submission was received.
What is the product code of K844694?
The FDA product code is HIT – Tester, Color Vision, a Class I (low risk) device regulated under 21 CFR 886.1170.