GUNKEL CHROMAGRAPH COLOR VISION TESTER
FDA 510(k) clearance K860174 · decided 1986-04-04
Clearance details
- K-number
- K860174
- Device name
- GUNKEL CHROMAGRAPH COLOR VISION TESTER
- Applicant
- Chromagraphics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-17
- Decision date
- 1986-04-04
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HIW
- Device class
- 1
- Regulation number
- 886.1070
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bethesda, MD, 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 |
|---|---|---|
| KAMPPETER ANOMALOSCOPE (K930575) | Bova Intl. | 1994-02-25 |
| ANOMALOSCOPE QUADRANT TEST-6 (K913962) | Lkc Technologies, Inc. | 1991-10-23 |
Recalls involving this device
No recalls on record reference this clearance.