ANOMALOSCOPE QUADRANT TEST-6
FDA 510(k) clearance K913962 · decided 1991-10-23
Clearance details
- K-number
- K913962
- Device name
- ANOMALOSCOPE QUADRANT TEST-6
- Applicant
- Lkc Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-05
- Decision date
- 1991-10-23
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- HIW
- Device class
- 1
- Regulation number
- 886.1070
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Gaithersburg, 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 |
| GUNKEL CHROMAGRAPH COLOR VISION TESTER (K860174) | Chromagraphics, Inc. | 1986-04-04 |
Recalls involving this device
No recalls on record reference this clearance.