The following data is part of a premarket notification filed by Electro-diagnostic Imaging, Inc. with the FDA for Edi Veris System.
| Device ID | K983983 |
| 510k Number | K983983 |
| Device Name: | 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 | 1998-11-09 |
| Decision Date | 1999-02-03 |
| Summary: | summary |