K854591 is an FDA 510(k) clearance for the SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ. This device is classified as a Monitor, Ultrasonic, Nonfetal (Class II - Special Controls, product code JAF).
Submitted by Philips Medical Systems, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 23, 1986, 156 days after receiving the submission on November 18, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1540.
| 510(k) Number | K854591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1985 |
| Decision Date | April 23, 1986 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | JAF — Monitor, Ultrasonic, Nonfetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1540 |