K925285 is an FDA 510(k) clearance for the DUALTHERM(R) CARDIAC OUTPUT COMPUTER. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 21, 1993, 274 days after receiving the submission on October 20, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K925285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1992 |
| Decision Date | July 21, 1993 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |