Animated Fixation Toys (Distance and Nearpoint)
FDA 510(k) K873914 · Richmond Products, Inc.
510(k) numberK873914
Submission
- Device name
- Animated Fixation Toys (Distance and Nearpoint)
- Applicant
- Richmond Products, Inc.
Boca Raton, FL, US - Received
- September 25, 1987
- Decision date
- December 11, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPL – Device, Fixation, Ac-Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1290
- Specialty
- Ophthalmic
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.)
Other 510(k)s with product code HPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931731 | Storz M824 Fixation Device for Retractive SurgeryHPL · Traditional | Storz Instrument Co. | 08/29/1994SE |
| K933739 | 360 Degree Fixation LightHPL · Traditional | Varitronics | 03/14/1994SE |
| K854383 | KeratoluxHPL · Traditional | Carl Zeiss, Inc. | 11/12/1985SE |
| K801381 | Fite Fixation Toy for Ocular ExamHPL · Traditional | Fite Engineering Corp. | 07/28/1980SE |
| K800112 | Amblyopia TrainerHPL · Traditional | Life-Tech Instruments, Inc. | 03/10/1980SE |
| K781313 | Vision-Stimulator, CamHPL · Traditional | Clement Clarke, Inc. | 01/26/1979SE |
More from Clement Clarke, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874252 | Kreda DiscHOQ · Traditional | 01/27/1988SE |
| K874251 | Worth 4 Dot Test Distance C/W Muscle LightHLP · Traditional | 01/11/1988SE |
| K874250 | Three Char. Test-Child & Worth 4 Dot Test Nearpt.HLP · Traditional | 01/11/1988SE |
| K873907 | Confirmation TestsHPC · Traditional | 12/29/1987SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | 12/23/1987SE |
| K873916 | 'E' Cube and 'E' PadHOX · Traditional | 12/11/1987SE |
| K873913 | Color Book Illuminator StandHJD · Traditional | 12/02/1987SE |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | 12/02/1987SE |
| K873917 | Tonometer TapesHKX · Traditional | 11/02/1987SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | 11/02/1987SE |
Questions and answers
When was Animated Fixation Toys (Distance and Nearpoint) cleared by the FDA?
Animated Fixation Toys (Distance and Nearpoint) (K873914) received a 510(k) decision of Substantially Equivalent on December 11, 1987, 77 days after the submission was received.
What is the product code of K873914?
The FDA product code is HPL – Device, Fixation, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1290.