K771977 is an FDA 510(k) clearance for the CARDIAC OUTPUT COMPUTER MODEL 701. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Instrumentation Laboratory CO (Walker, US). The FDA issued a Cleared decision on January 3, 1978, 78 days after receiving the submission on October 17, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K771977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1977 |
| Decision Date | January 03, 1978 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSK — Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |