Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series— 510(k) K163113

Substantially Equivalent

Grandway Technology (Shenzhen) Limited

FDA 510(k) clearance K163113 for Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, Substantially Equivalent on 2017-01-19. Applicant: Grandway Technology (Shenzhen) Limited.

Clearance details

Applicant: Grandway Technology (Shenzhen) Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2016-11-07
Decision date: 2017-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, 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.