Spot Retinoscope RX-3SP
FDA 510(k) K950793 · Neitz Instruments Company, Ltd.
510(k) numberK950793
Submission
- Device name
- Spot Retinoscope RX-3SP
- Applicant
- Neitz Instruments Company, Ltd.
Tokyo, JP - Received
- February 21, 1995
- Decision date
- March 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HKM – Retinoscope, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1780
- Specialty
- Ophthalmic
Other 510(k)s with product code HKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964338 | Ri-Tiniscope-Slit/Ri-Tiniscope Spot/Ri-Vision-Slit/Ri-Vision-SpotHKM · Traditional | Rudolf Riester GmbH & Co. KG | 01/09/1997SE |
| K950795 | Streak Retinoscope Rx-RpHKM · Traditional | Neitz Instruments Company, Ltd. | 03/28/1995SE |
| K950794 | Streak Retinoscope Rx-RcHKM · Traditional | Neitz Instruments Company, Ltd. | 03/28/1995SE |
| K950792 | Streak Retinoscope RX-3AHKM · Traditional | Neitz Instruments Company, Ltd. | 03/28/1995SE |
| K950791 | Streak Retinoscope RX-3HKM · Traditional | Neitz Instruments Company, Ltd. | 03/28/1995SE |
| K840840 | Generated Retinal Reflex Imagery SysHKM · Traditional | Electro Optical Instruments | 07/12/1984SE |
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| 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 |
| K950792 | Streak Retinoscope RX-3AHKM · Traditional | 03/28/1995SE |
Questions and answers
When was Spot Retinoscope RX-3SP cleared by the FDA?
Spot Retinoscope RX-3SP (K950793) received a 510(k) decision of Substantially Equivalent on March 28, 1995, 35 days after the submission was received.
What is the product code of K950793?
The FDA product code is HKM – Retinoscope, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.1780.