The following data is part of a premarket notification filed by Electro-diagnostic Imaging, Inc. with the FDA for Modification To Edi Veris System.
| Device ID | K003442 |
| 510k Number | K003442 |
| Device Name: | MODIFICATION TO EDI VERIS SYSTEM |
| Classification | Photostimulator, Ac-powered |
| Applicant | ELECTRO-DIAGNOSTIC IMAGING, INC. 2081 LONGDEN CIRCLE Los Altos, CA 94024 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering ELECTRO-DIAGNOSTIC IMAGING, INC. 2081 LONGDEN CIRCLE Los Altos, CA 94024 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-06 |
| Decision Date | 2001-05-04 |