Arm Blood Pressure Monitor (model: BPM-A7VL)— 510(k) K243118

Substantially Equivalent

Shenzhen Imdk Medical Technology Co., Ltd.

FDA 510(k) clearance K243118 for Arm Blood Pressure Monitor (model: BPM-A7VL), Substantially Equivalent on 2024-11-26. Applicant: Shenzhen Imdk Medical Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Imdk Medical Technology Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2024-09-30
Decision date: 2024-11-26
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.