The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Medacord Pvl, Personal Vascular Laboratory.
| Device ID | K882018 |
| 510k Number | K882018 |
| Device Name: | MEDACORD PVL, PERSONAL VASCULAR LABORATORY |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | MEDASONICS, INC. 82 PIONEER WAY P.O. BOX 7268 Mountain View, CA 94042 |
| Contact | Qilliam E Mckay |
| Correspondent | Qilliam E Mckay MEDASONICS, INC. 82 PIONEER WAY P.O. BOX 7268 Mountain View, CA 94042 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-13 |
| Decision Date | 1988-09-21 |