The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Advanced Diagnostic Viewer (adv).
| Device ID | K963697 |
| 510k Number | K963697 |
| Device Name: | ADVANCED DIAGNOSTIC VIEWER (ADV) |
| Classification | System, Image Processing, Radiological |
| Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Bruce A Macfarlane, Ph.d. |
| Correspondent | Bruce A Macfarlane, Ph.d. BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-11-27 |
| Summary: | summary |