Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)— 510(k) K241431

Substantially Equivalent

Joytech Healthcare Co. , Ltd.

FDA 510(k) clearance K241431 for Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193), Substantially Equivalent on 2025-01-13. Applicant: Joytech Healthcare Co. , Ltd..

Clearance details

Applicant: Joytech Healthcare Co. , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2024-05-21
Decision date: 2025-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, 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.