510(k) K914393
- Device
- Retina Tester
- Applicant
- RETINA TESTER
- 510(k) number
- K914393
- Product code
- HLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-02
- Date received
- 1991-10-01
- Regulation
- 886.1630
- Classification name
- Photostimulator, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- IRBY SEAY
- Address
- 3637 Park Ave. Memphis TN US 38111 38111
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HLX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003442 | MODIFICATION TO EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | 2001-05-04 |
| K983983 | EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | 1999-02-03 |
| K925741 | CLARUS ENDOSCOPIC HOOK KNIFE | Clarus Medical Systems, Inc. | 1993-08-24 |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Lkc Technologies, Inc. | 1991-10-25 |
| K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR | Randwal Instrument Co., Inc. | 1988-02-05 |
| K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | Biosan Laboratories, Inc. | 1985-11-01 |
| K833446 | DOWNING SPECTRAL ILLUMINATOR | Vision Health Technology | 1984-03-12 |
| K832762 | MILLER/NADLER GLARE TESTER | Titmus Optical, Inc. | 1983-09-29 |
| K831231 | LED GOGGLES | Cadwell Laboratories, Inc. | 1983-05-16 |
| K830770 | CONTRAST SENSITIVITY EQUIPMENT | Cadwell Laboratories, Inc. | 1983-04-28 |
| K822923 | 5012 PARABOLIC STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 |
| K822922 | 5011 GANZFELD STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 |
| K822919 | 5010 VISUSTIM | Life-Tech Intl., Inc. | 1982-12-28 |
| K822915 | 5031 BRIGHT FLASH STIMULATOR | Life-Tech Intl., Inc. | 1982-12-28 |
| K812331 | VTS-1000 VISUAL TESTING SYSTEM | Nicolet Biomedical Instruments | 1981-11-16 |