K183521 is an FDA 510(k) clearance for the CNAP Monitor. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Cnsystems Medizintechnik GmbH (Graz, AT). The FDA issued a Cleared decision on September 11, 2019, 266 days after receiving the submission on December 19, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K183521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2018 |
| Decision Date | September 11, 2019 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |