K192092 is an FDA 510(k) clearance for the Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Seca GmbH & Co. KG (Hamburg, DE). The FDA issued a Cleared decision on January 23, 2020, 171 days after receiving the submission on August 5, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K192092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2019 |
| Decision Date | January 23, 2020 |
| Days to Decision | 171 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 |