510(k) K840840
- Device
- Generated Retinal Reflex Imagery Sys
- Applicant
- ELECTRO OPTICAL INSTRUMENTS
- 510(k) number
- K840840
- Product code
- HKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-12
- Date received
- 1984-02-24
- Regulation
- 886.1780
- Classification name
- Retinoscope, Battery-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 3033536319
- 3004095901
- 3013298431
- 1316463
- 8043512
- 3014579161
- 3009275598
- 3011898560
- 1036862
- 3006252153
- 3013846070
- 8010482
- 3005785090
- 3007343325
- 3006087789
- 1926681
- 1820463
- 1000379039
- 3013436538
- 3003553186
- 3007584446
- 2031962
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HKM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964338 | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT | Rudolf Riester GmbH & Co. KG | 1997-01-09 |
| K950791 | STREAK RETINOSCOPE RX-3 | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950792 | STREAK RETINOSCOPE RX-3A | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950793 | SPOT RETINOSCOPE RX-3SP | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950794 | STREAK RETINOSCOPE RX-RC | Neitz Instruments Company, Ltd. | 1995-03-28 |
| K950795 | STREAK RETINOSCOPE RX-RP | Neitz Instruments Company, Ltd. | 1995-03-28 |