The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Vasculab Bi-directional Doppler, #d10.
| Device ID | K800768 |
| 510k Number | K800768 |
| Device Name: | VASCULAB BI-DIRECTIONAL DOPPLER, #D10 |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | MEDASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-07 |
| Decision Date | 1980-07-08 |