Woodlyn Ophthalmic Projector
FDA 510(k) K890992 · Woodlyn, Inc.
510(k) numberK890992
Submission
- Device name
- Woodlyn Ophthalmic Projector
- Applicant
- Woodlyn, Inc.
Arlington Heights, IL, US - Received
- February 27, 1989
- Decision date
- May 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOS – Projector, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1680
- Specialty
- Ophthalmic
Other 510(k)s with product code HOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K936200 | Wireless Chart Projector,Hcp-W 721HOS · Traditional | Canon USA, Inc. | 09/28/1994SE |
| K930443 | Marco CP-600 Auto Chart PROJECTOR/CP-1 Chart ProjeHOS · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K924784 | Burton Projector Head - Model 6000-HHOS · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K921214 | Ophthalmic ProjectorHOS · Traditional | Luneau Ophtalmologie SA | 06/11/1992SE |
| K862519 | Bausch & Lomb Accu-Chart 3 Acuity ProjectorHOS · Traditional | Bausch & Lomb, Inc. | 07/23/1986SE |
| K812706 | Miller/Nadler Glare TesterHOS · Traditional | Mosebach Electric & Supply | 11/16/1981SE |
| K811180 | Ultramatic Project-O-Chart Ophth. ProjHOS · Traditional | American Optical Corp. | 05/15/1981SE |
| K781658 | Projector, Accu-Chart AcuityHOS · Traditional | Bausch & Lomb, Inc. | 10/17/1978SE |
More from Bausch & Lomb, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931303 | Woodlyn Operation MicroscopeFSO · Traditional | 06/25/1993SE |
| K920861 | Woodlyn Classic LensmeterHLM · Traditional | 07/30/1992SE |
| K900478 | Woodlyn Full Aperture Trial Lens SetHPC · Traditional | 02/21/1990SE |
| K900477 | Woodlyn Classic Slit Lamp Model SMMHJO · Traditional | 02/21/1990SE |
| K900476 | Woodlyn Slit Lamp Model HR-1HJO · Traditional | 02/21/1990SE |
| K874900 | Woodlyn Classic Refractor, PhoroptorHKN · Traditional | 12/23/1987SE |
| K843812 | Woodlyn Classic Cataract Acuity TestHLI · Traditional | 12/11/1984SE |
| K841767 | Woodlyn Classic KeratometerHLI · Traditional | 08/07/1984SE |
| K841765 | Woodlyn Standard Slit Lamp Hssl-StHLQ · Traditional | 08/07/1984SE |
| K841764 | Woodlyn Classic Javal OphthalmometerHLI · Traditional | 08/07/1984SE |
Questions and answers
When was Woodlyn Ophthalmic Projector cleared by the FDA?
Woodlyn Ophthalmic Projector (K890992) received a 510(k) decision of Substantially Equivalent on May 17, 1989, 79 days after the submission was received.
What is the product code of K890992?
The FDA product code is HOS – Projector, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1680.