Product code HIT
- Device name
- Tester, Color Vision
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1170
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K903001 | SLIMCATH (TM) | Gynopharma, Inc. | 1991-06-25 |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Lkc Technologies, Inc. | 1988-02-05 |
| K873908 | H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. | Richmond Products, Inc. | 1987-12-23 |
| K873911 | PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 | Richmond Products, Inc. | 1987-12-02 |
| K844694 | TITMUS VISION TESTER II | Titmus Optical, Inc. | 1985-01-22 |
| K844365 | COLOR VISION TESTERS | Luneau Laboratories | 1985-01-02 |
| K832843 | OSCAR COLOUR VISION TESTER | Keeler Instruments, Inc. | 1984-01-04 |
| K831074 | OSCAR COLOR VISION TESTER | Carl Zeiss, Inc. | 1983-04-28 |
| K810700 | CHROMOPS FM-100 COLOR VISION TESTER | Visidyne Corp. | 1981-04-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810101280498 | bili-ruler | LITTLE SPARROWS TECHNOLOGIES LLC | 2026-04-07 |
| 00860010709719 | Virtual Eye PRO | Virtual Vision Health | 2024-12-16 |
| 00860010709726 | Virtual Eye ELITE S | Virtual Vision Health | 2024-12-16 |
| 00860010709795 | Virtual Eye Software | Virtual Vision Health | 2024-12-16 |
| 00860010709788 | Virtual Eye Software | Virtual Vision Health | 2024-11-27 |
| 00860010709757 | Virtual Eye Software | Virtual Vision Health | 2024-08-20 |
| 00860010709740 | Virtual Eye Software | Virtual Vision Health | 2024-05-07 |
| 00860010709733 | Virtual Eye Software | Virtual Vision Health | 2024-02-27 |
| 00860001720433 | Virtual Field | Virtual Field, Inc. | 2023-11-08 |
| G506NC010 | NeuroColor | AMA Optics, Inc. | 2023-09-30 |
| 04582275270068 | NA | KONAN MEDICAL USA, INC. | 2023-06-15 |
| 00860001720419 | Virtual Field | Virtual Field, Inc. | 2023-01-23 |
| 00860001720426 | Virtual Field | Virtual Field, Inc. | 2023-01-23 |
| 00860001720402 | Virtual Field | Virtual Field, Inc. | 2023-01-23 |
| 04049584014795 | C-Quant | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2022-12-07 |
| 06971821401038 | Computerized vision tester | Ningbo Ming Sing Optical R & D Co., Ltd. | 2020-08-20 |
| 06971821401021 | COMPUTERIZED VISION TESTER | Ningbo Ming Sing Optical R & D Co., Ltd. | 2019-12-02 |