K800025 is an FDA 510(k) clearance for the DINAMAP RESEARCH MONITOR 1245. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on February 1, 1980, 25 days after receiving the submission on January 7, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K800025 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1980 |
| Decision Date | February 01, 1980 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |