K873914 is an FDA 510(k) clearance for the ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT). This device is classified as a Device, Fixation, Ac-powered, Ophthalmic (Class I - General Controls, product code HPL).
Submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 11, 1987, 77 days after receiving the submission on September 25, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1290. A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.).
| 510(k) Number | K873914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1987 |
| Decision Date | December 11, 1987 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPL — Device, Fixation, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1290 |
| Definition | A Fixation Device Is An Ac-powered Device Intended For Use As A Fixation Target For The Patient During Ophthalmologic Examination. The Patient Directs His Or Her Gaze So That The Visual Image Of The Object Falls On The Fovea Centralis (the Center Of The Macular Retina Of The Eye.) |