Ocs 100 (Ocular Comparator System)
FDA 510(k) K874220 · Ocular Instruments, Inc.
510(k) numberK874220
Submission
- Device name
- Ocs 100 (Ocular Comparator System)
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- October 16, 1987
- Decision date
- December 23, 1987
- 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
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| 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 |
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| K923670 | Byrne Expulsive LensHJI · Traditional | 11/16/1992SE |
| K921414 | Trokel /3 Gonio Laser LensLQJ · Traditional | 11/16/1992SE |
| K914051 | Pediatric Vitrectomy Lens SetHJK · Traditional | 12/09/1991SE |
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Questions and answers
When was Ocs 100 (Ocular Comparator System) cleared by the FDA?
Ocs 100 (Ocular Comparator System) (K874220) received a 510(k) decision of Substantially Equivalent on December 23, 1987, 68 days after the submission was received.
What is the product code of K874220?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.