Woodlyn Classic Instrument Stand
FDA 510(k) K841760 · Woodlyn, Inc.
510(k) numberK841760
Submission
- Device name
- Woodlyn Classic Instrument Stand
- Applicant
- Woodlyn, Inc.
Mchenry, IL, US - Received
- April 27, 1984
- Decision date
- June 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HRJ – Table, Instrument, Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4855
- Specialty
- Ophthalmic
Other 510(k)s with product code HRJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930447 | Marco H and TS-1 Instrument TablesHRJ · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K922242 | 910T Montorized Instrument TableHRJ · Traditional | R.H. Burton Co. | 09/30/1992SE |
| K912134 | TBD, Lens Measuring DeviceHRJ · Traditional | Alcon Laboratories | 07/25/1991SE |
| K853744 | Techna Vision, Inc.Electric TableHRJ · Traditional | Techna Vision | 10/17/1985SE |
| K853359 | Reliance 1379HRJ · Traditional | Dentsply Intl. | 09/24/1985SE |
| K833820 | Machemer/Tano RotatingHRJ · Traditional | Optical Micro Systems, Inc. | 01/04/1984SE |
More from Optical Micro Systems, 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 |
| 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 Instrument Stand cleared by the FDA?
Woodlyn Classic Instrument Stand (K841760) received a 510(k) decision of Substantially Equivalent on June 19, 1984, 53 days after the submission was received.
What is the product code of K841760?
The FDA product code is HRJ – Table, Instrument, Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4855.