K912925 is an FDA 510(k) clearance for the ULTRA PVD. This device is classified as a Monitor, Ultrasonic, Nonfetal (Class II - Special Controls, product code JAF).
Submitted by Advanced Medical Products, Inc. (Washington, US). The FDA issued a Cleared decision on June 18, 1992, 351 days after receiving the submission on July 3, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1540.
| 510(k) Number | K912925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1991 |
| Decision Date | June 18, 1992 |
| Days to Decision | 351 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAF — Monitor, Ultrasonic, Nonfetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1540 |