Neitz Slit Lamp SL-H2
FDA 510(k) K951341 · Neitz Instruments Company, Ltd.
510(k) numberK951341
Submission
- Device name
- Neitz Slit Lamp SL-H2
- Applicant
- Neitz Instruments Company, Ltd.
Tokyo, JP - Received
- March 24, 1995
- Decision date
- June 15, 1995
- 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
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| 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 |
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| 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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| K972440 | Cataractscreener CT - SHKI · Traditional | 09/30/1997SE |
| K951337 | Fiber Head Light FH-300HPQ · Traditional | 06/08/1995SE |
| K950788 | Otoscope A-34ERA · Traditional | 05/03/1995SE |
| K951340 | Neitz Slit Lamp SL-H1HJO · Traditional | 04/10/1995SE |
| K951338 | Indirect Ophthalmoscope Video System IO0 a TVHLI · Traditional | 04/07/1995SE |
| K950797 | Halogen Ophthalmo-Otoscope Set BX a - 134HLJ · Traditional | 03/28/1995SE |
| K950795 | Streak Retinoscope Rx-RpHKM · Traditional | 03/28/1995SE |
| K950794 | Streak Retinoscope Rx-RcHKM · Traditional | 03/28/1995SE |
| K950793 | Spot Retinoscope RX-3SPHKM · Traditional | 03/28/1995SE |
| K950792 | Streak Retinoscope RX-3AHKM · Traditional | 03/28/1995SE |
Questions and answers
When was Neitz Slit Lamp SL-H2 cleared by the FDA?
Neitz Slit Lamp SL-H2 (K951341) received a 510(k) decision of Substantially Equivalent on June 15, 1995, 83 days after the submission was received.
What is the product code of K951341?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.