OSCAR COLOR VISION TESTER
FDA 510(k) clearance K831074 · decided 1983-04-28
Clearance details
- K-number
- K831074
- Device name
- OSCAR COLOR VISION TESTER
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-04
- Decision date
- 1983-04-28
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- HIT
- Device class
- 1
- Regulation number
- 886.1170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| CHROMOPS FM-100 COLOR VISION TESTER (K810700) | Visidyne Corp. | 1981-04-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |