EDI VERIS SYSTEM
FDA 510(k) clearance K983983 · decided 1999-02-03
Clearance details
- K-number
- K983983
- Device name
- EDI VERIS SYSTEM
- Applicant
- Electro-Diagnostic Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-09
- Decision date
- 1999-02-03
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HLX
- Device class
- 2
- Regulation number
- 886.1630
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Los Altos, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO EDI VERIS SYSTEM (K003442) | Electro-Diagnostic Imaging, Inc. | 2001-05-04 |
| CLARUS ENDOSCOPIC HOOK KNIFE (K925741) | Clarus Medical Systems, Inc. | 1993-08-24 |
| RETINA TESTER (K914393) | Retina Tester | 1992-03-02 |
| SCOPTOPIC SENSITIVITY TEST-1[SST-1] (K914163) | Lkc Technologies, Inc. | 1991-10-25 |
| IRAS EDS INTERFEROMETRIC STIMULATOR (K873990) | Randwal Instrument Co., Inc. | 1988-02-05 |
| PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (K853812) | Biosan Laboratories, Inc. | 1985-11-01 |
| DOWNING SPECTRAL ILLUMINATOR (K833446) | Vision Health Technology | 1984-03-12 |
| MILLER/NADLER GLARE TESTER (K832762) | Titmus Optical, Inc. | 1983-09-29 |
| LED GOGGLES (K831231) | Cadwell Laboratories, Inc. | 1983-05-16 |
| CONTRAST SENSITIVITY EQUIPMENT (K830770) | Cadwell Laboratories, Inc. | 1983-04-28 |
| 5012 PARABOLIC STIMULATOR (K822923) | Life-Tech Intl., Inc. | 1982-12-28 |
| 5011 GANZFELD STIMULATOR (K822922) | Life-Tech Intl., Inc. | 1982-12-28 |
Recalls involving this device
No recalls on record reference this clearance.