Aesculap-Meditec Slit Lamps SL07 and SL08
FDA 510(k) K974467 · Aesculap-Meditec North America
510(k) numberK974467
Submission
- Device name
- Aesculap-Meditec Slit Lamps SL07 and SL08
- Applicant
- Aesculap-Meditec North America
Coto De Caza, CA, US - Received
- November 26, 1997
- Decision date
- February 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
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| 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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Questions and answers
When was Aesculap-Meditec Slit Lamps SL07 and SL08 cleared by the FDA?
Aesculap-Meditec Slit Lamps SL07 and SL08 (K974467) received a 510(k) decision of Substantially Equivalent on February 19, 1998, 85 days after the submission was received.
What is the product code of K974467?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.