DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143— 510(k) K092683

Substantially Equivalent

Shanghai Little Doctor Co. Limited

FDA 510(k) clearance K092683 for DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143, Substantially Equivalent on 2009-09-25. Applicant: Shanghai Little Doctor Co. Limited.

Clearance details

Applicant: Shanghai Little Doctor Co. Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-09-01
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Nantong, Jiangsu, 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.