K170866 is an FDA 510(k) clearance for the Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Honsun (Nantong) Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on February 21, 2018, 335 days after receiving the submission on March 23, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K170866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2017 |
| Decision Date | February 21, 2018 |
| Days to Decision | 335 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |