HIT
9 FDA 510(k) clearances · Product code
60 daysmedian time to decision
351 days90th percentile
9clearances measured
FDA profile
- Official device name
- Tester, Color Vision
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1170
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SLIMCATH (TM) (K903001) | Gynopharma, Inc. | 1991-06-25 |
| ANOMALOSCOPE PLATE TEST - 5 [APT-5] (K875026) | Lkc Technologies, Inc. | 1988-02-05 |
| H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (K873908) | Richmond Products, Inc. | 1987-12-23 |
| PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (K873911) | Richmond Products, Inc. | 1987-12-02 |
| TITMUS VISION TESTER II (K844694) | Titmus Optical, Inc. | 1985-01-22 |
| COLOR VISION TESTERS (K844365) | Luneau Laboratories | 1985-01-02 |
| OSCAR COLOUR VISION TESTER (K832843) | Keeler Instruments, Inc. | 1984-01-04 |
| OSCAR COLOR VISION TESTER (K831074) | Carl Zeiss, Inc. | 1983-04-28 |
| CHROMOPS FM-100 COLOR VISION TESTER (K810700) | Visidyne Corp. | 1981-04-10 |
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