Automatic Arm Bluetooth Blood Pressure Monitor— 510(k) K161846

Substantially Equivalent

Truly Instrument Limited

FDA 510(k) clearance K161846 for Automatic Arm Bluetooth Blood Pressure Monitor, Substantially Equivalent on 2016-10-24. Applicant: Truly Instrument Limited.

Clearance details

Applicant: Truly Instrument Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2016-07-05
Decision date: 2016-10-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shanwei, 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.