Woodlyn Classic Javal Ophthalmometer
FDA 510(k) K841764 · Woodlyn, Inc.
510(k) numberK841764
Submission
- Device name
- Woodlyn Classic Javal Ophthalmometer
- Applicant
- Woodlyn, Inc.
Mchenry, IL, US - Received
- April 27, 1984
- Decision date
- August 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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More from Bioptigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931303 | Woodlyn Operation MicroscopeFSO · Traditional | 06/25/1993SE |
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| 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 |
| K890992 | Woodlyn Ophthalmic ProjectorHOS · Traditional | 05/17/1989SE |
| 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 |
Questions and answers
When was Woodlyn Classic Javal Ophthalmometer cleared by the FDA?
Woodlyn Classic Javal Ophthalmometer (K841764) received a 510(k) decision of Substantially Equivalent on August 7, 1984, 102 days after the submission was received.
What is the product code of K841764?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.