K904832 is an FDA 510(k) clearance for the MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on April 22, 1991, 181 days after receiving the submission on October 23, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K904832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1990 |
| Decision Date | April 22, 1991 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXK — Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |