Burton Slit Lamp - Model 2000
FDA 510(k) K924782 · R.H. Burton Co.
510(k) numberK924782
Submission
- Device name
- Burton Slit Lamp - Model 2000
- Applicant
- R.H. Burton Co.
Grove City, OH, US - Received
- September 23, 1992
- Decision date
- January 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
Other 510(k)s with product code HJO
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|---|---|---|---|
| K253834 | Visuref 600HJO · Traditional | Carl Zeiss Vision GmbH | 03/18/2026SE |
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | Cylite Pty. , Ltd. | 03/08/2024SE |
| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 01/14/2020SE |
| K182306 | Sunkingdom Slit LampHJO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 11/22/2018SE |
| K173771 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 08/24/2018SE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
More from Carl Zeiss Meditec, AG
| 510(k) | Device | Decision |
|---|---|---|
| K924773 | Burton H- Base Table - Model 1990HRX · Traditional | 06/07/1993SE |
| K924786 | Burton Trial Lens SetHPC · Traditional | 04/14/1993SE |
| K924783 | Burton Slit Lamp - Model 850HJO · Traditional | 04/14/1993SE |
| K924774 | Burton Automatic Projector - Model CP-40HOD · Traditional | 04/14/1993SE |
| K924790 | Burton Auto Refractor - Model BAR-7HKO · Traditional | 04/05/1993SE |
| K924788 | Burton LensmeterHLM · Traditional | 04/05/1993SE |
| K924785 | Burton Radiusgauge - Model 2030HLM · Traditional | 04/05/1993SE |
| K924784 | Burton Projector Head - Model 6000-HHOS · Traditional | 04/05/1993SE |
| K924780 | Burton Ophthalmic Exam Unit - Model 2201HMF · Traditional | 04/05/1993SE |
| K924779 | Burton Keratometer - Modle 2040HJB · Traditional | 04/05/1993SE |
Questions and answers
When was Burton Slit Lamp - Model 2000 cleared by the FDA?
Burton Slit Lamp - Model 2000 (K924782) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 126 days after the submission was received.
What is the product code of K924782?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.