The following data is part of a premarket notification filed by Advance Medical Device, Inc. with the FDA for Floscope Super Vascular Lab.
| Device ID | K943200 |
| 510k Number | K943200 |
| Device Name: | FLOSCOPE SUPER VASCULAR LAB |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | ADVANCE MEDICAL DEVICE, INC. P. O. BOX 1419 Camden, NJ 08105 |
| Contact | David Lerner |
| Correspondent | David Lerner ADVANCE MEDICAL DEVICE, INC. P. O. BOX 1419 Camden, NJ 08105 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1995-11-21 |