The following data is part of a premarket notification filed by Advanced Medical Products, Inc. with the FDA for Ultra Pvd.
| Device ID | K912925 |
| 510k Number | K912925 |
| Device Name: | ULTRA PVD |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | ADVANCED MEDICAL PRODUCTS, INC. 1575 EYE ST. N.W. Washington, DC 20005 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone ADVANCED MEDICAL PRODUCTS, INC. 1575 EYE ST. N.W. Washington, DC 20005 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-03 |
| Decision Date | 1992-06-18 |