Richmond Visual Field Screener
FDA 510(k) K873912 · Richmond Products, Inc.
510(k) numberK873912
Submission
- Device name
- Richmond Visual Field Screener
- Applicant
- Richmond Products, Inc.
Boca Raton, FL, US - Received
- September 25, 1987
- Decision date
- November 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOO – Perimeter, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
Other 510(k)s with product code HOO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941723 | Welch Allyn Glaucoma DetectorHOO · Traditional | Welch Allyn, Inc. | 06/06/1994SE |
| K930448 | Marco Projection PerimeterHOO · Traditional | Marco Ophthalmic, Inc. | 06/21/1993SE |
| K864467 | Henson - Hamblin CFS 2000 Central Field ScreenHOO · Traditional | Keeler Instruments, Inc. | 12/15/1986SE |
| K860115 | Digilab Cambridge PerimeterHOO · Traditional | Bio-Rad | 02/27/1986SE |
| K832800 | Automatic Tangent Screen 50HOO · Traditional | CooperVision, Inc. | 09/29/1983SE |
More from CooperVision, 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 |
| K873914 | Animated Fixation Toys (Distance and Nearpoint)HPL · 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 |
Questions and answers
When was Richmond Visual Field Screener cleared by the FDA?
Richmond Visual Field Screener (K873912) received a 510(k) decision of Substantially Equivalent on November 2, 1987, 38 days after the submission was received.
What is the product code of K873912?
The FDA product code is HOO – Perimeter, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.