K771991 is an FDA 510(k) clearance for the CARDIAC OUTPUT THERMODILUTION MODULE. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 3, 1977, 15 days after receiving the submission on October 19, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K771991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1977 |
| Decision Date | November 03, 1977 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXG — Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |