Tester, Color Vision
The Color Vision Tester is an ophthalmic diagnostic device used to assess a patient's ability to distinguish colors, typically used to detect color vision deficiencies such as color blindness. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no requirement for premarket notification or approval. The product code is HIT, regulated under 21 CFR 886.1170, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
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Basic Information
- Product Code
- HIT
- Device Class
- FDA class 1
- Regulation Number
- 886.1170
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K903001 | SLIMCATH (TM) | Jun 25, 1991 | Substantially Equivalent | Gynopharma, Inc. |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Feb 05, 1988 | Substantially Equivalent | Lkc Technologies, Inc. |
| K873908 | H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. | Dec 23, 1987 | Substantially Equivalent | Richmond Products, Inc. |
| K873911 | PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 | Dec 02, 1987 | Substantially Equivalent | Richmond Products, Inc. |
| K844694 | TITMUS VISION TESTER II | Jan 22, 1985 | Substantially Equivalent | Titmus Optical, Inc. |
| K844365 | COLOR VISION TESTERS | Jan 02, 1985 | Substantially Equivalent | Luneau Laboratories |
| K832843 | OSCAR COLOUR VISION TESTER | Jan 04, 1984 | Substantially Equivalent | Keeler Instruments, Inc. |
| K831074 | OSCAR COLOR VISION TESTER | Apr 28, 1983 | Substantially Equivalent | Carl Zeiss, Inc. |
| K810700 | CHROMOPS FM-100 COLOR VISION TESTER | Apr 10, 1981 | Substantially Equivalent | Visidyne Corp. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.