510(k) K252501— Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)

Substantially Equivalent

Joytech Healthcare Co. , Ltd.

Clearance details

Applicant: Joytech Healthcare Co. , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2025-08-08
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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.