Abbott Globe Holder
FDA 510(k) K832911 · Miami Eye Technology, Inc.
510(k) numberK832911
Submission
- Device name
- Abbott Globe Holder
- Applicant
- Miami Eye Technology, Inc.
Mchenry, IL, US - Received
- August 29, 1983
- Decision date
- September 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K841101 | Clayman-Parel Capsule CoupeurHNY · Traditional | 05/16/1984SE |
| K832912 | Gelender Vacuum Fixation Ring SysHNH · Traditional | 01/10/1984SE |
| K832996 | Surgical Iop MonitorHKY · Traditional | 11/28/1983SE |
| K832997 | Epa Automated Infusion PoleHQC · Traditional | 10/04/1983SE |
| K831702 | Rare-Earth Intra-Ocular MagnetHPN · Traditional | 06/30/1983SE |
Questions and answers
When was Abbott Globe Holder cleared by the FDA?
Abbott Globe Holder (K832911) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 31 days after the submission was received.
What is the product code of K832911?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.