Generated Retinal Reflex Imagery Sys
FDA 510(k) K840840 · Electro Optical Instruments
510(k) numberK840840
Submission
- Device name
- Generated Retinal Reflex Imagery Sys
- Applicant
- Electro Optical Instruments
Mchenry, IL, US - Received
- February 24, 1984
- Decision date
- July 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K950793 | Spot Retinoscope RX-3SPHKM · 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 |
Questions and answers
When was Generated Retinal Reflex Imagery Sys cleared by the FDA?
Generated Retinal Reflex Imagery Sys (K840840) received a 510(k) decision of Substantially Equivalent on July 12, 1984, 139 days after the submission was received.
What is the product code of K840840?
The FDA product code is HKM – Retinoscope, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.1780.