K782073 is an FDA 510(k) clearance for the DINAMAP MODELS 1160 AND 1165. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Applied Medical Research (Walker, US). The FDA issued a Cleared decision on February 23, 1979, 72 days after receiving the submission on December 13, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K782073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1978 |
| Decision Date | February 23, 1979 |
| Days to Decision | 72 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 |