510(k) K873914
K873914 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)". The FDA issued a decision of Substantially Equivalent on December 11, 1987. The device falls under product code HPL (Device, Fixation, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1290. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1987
- Date Received
- September 25, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Ac-Powered, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1290
- Review Panel
- OP
- Submission Type
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.)