Modification to Edi Veris System
FDA 510(k) K003442 · Electro-Diagnostic Imaging, Inc.
510(k) numberK003442
Submission
- Device name
- Modification to Edi Veris System
- Applicant
- Electro-Diagnostic Imaging, Inc.
Los Altos, CA, US - Received
- November 6, 2000
- Decision date
- May 4, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLX – Photostimulator, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1630
- Specialty
- Ophthalmic
Other 510(k)s with product code HLX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983983 | Edi Veris SystemHLX · Traditional | Electro-Diagnostic Imaging, Inc. | 02/03/1999SE |
| K925741 | Clarus Endoscopic Hook KnifeHLX · Traditional | Clarus Medical Systems, Inc. | 08/24/1993SE |
| K914393 | Retina TesterHLX · Traditional | Retina Tester | 03/02/1992SE |
| K914163 | Scoptopic Sensitivity TEST-1[SST-1]HLX · Traditional | Lkc Technologies, Inc. | 10/25/1991SE |
| K873990 | Iras Eds Interferometric StimulatorHLX · Traditional | Randwal Instrument Co., Inc. | 02/05/1988SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | Biosan Laboratories, Inc. | 11/01/1985SE |
| K833446 | Downing Spectral IlluminatorHLX · Traditional | Vision Health Technology | 03/12/1984SE |
| K832762 | Miller/Nadler Glare TesterHLX · Traditional | Titmus Optical, Inc. | 09/29/1983SE |
| K831231 | LED GogglesHLX · Traditional | Cadwell Laboratories, Inc. | 05/16/1983SE |
| K830770 | Contrast Sensitivity EquipmentHLX · Traditional | Cadwell Laboratories, Inc. | 04/28/1983SE |
More from Cadwell Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983983 | Edi Veris SystemHLX · Traditional | 02/03/1999SE |
Questions and answers
When was Modification to Edi Veris System cleared by the FDA?
Modification to Edi Veris System (K003442) received a 510(k) decision of Substantially Equivalent on May 4, 2001, 179 days after the submission was received.
What is the product code of K003442?
The FDA product code is HLX – Photostimulator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1630.