K843555 is an FDA 510(k) clearance for the CARDIAC COMPUTER SP1445. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Gould, Inc. (Oxnard, US). The FDA issued a Cleared decision on February 1, 1985, 144 days after receiving the submission on September 10, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K843555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1984 |
| Decision Date | February 01, 1985 |
| Days to Decision | 144 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 |