XM-01 Electronic Automatic Blood Pressure Monitor— 510(k) K150908

Substantially Equivalent

Sky Innovation Technology ( Shanghai) Limited

FDA 510(k) clearance K150908 for XM-01 Electronic Automatic Blood Pressure Monitor, Substantially Equivalent on 2015-12-16. Applicant: Sky Innovation Technology ( Shanghai) Limited.

Clearance details

Applicant: Sky Innovation Technology ( Shanghai) Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-04-03
Decision date: 2015-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.