Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series— 510(k) K163648

Substantially Equivalent

Grandway Technology (Shenzhen) Limited

FDA 510(k) clearance K163648 for Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series, Substantially Equivalent on 2017-07-07. Applicant: Grandway Technology (Shenzhen) Limited.

Clearance details

Applicant: Grandway Technology (Shenzhen) Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2016-12-23
Decision date: 2017-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
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.