The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Flostat Vascular Report Generator (vrg).
| Device ID | K973857 |
| 510k Number | K973857 |
| Device Name: | FLOSTAT VASCULAR REPORT GENERATOR (VRG) |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | BIOMEDIX, INC. P.O. BOX 1419 Camden, NJ 08105 |
| Contact | David Lerner |
| Correspondent | David Lerner BIOMEDIX, 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 | 1997-10-09 |
| Decision Date | 1997-12-29 |