K170466 is an FDA 510(k) clearance for the Automatic Blood Pressure Monitor Model LD-518 & LD-537. 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 October 27, 2017, 254 days after receiving the submission on February 15, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K170466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2017 |
| Decision Date | October 27, 2017 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| 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 |