BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE— 510(k) K091553

Substantially Equivalent

Ningbo Diaier Electronic Co., Ltd.

FDA 510(k) clearance K091553 for BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE, Substantially Equivalent on 2009-09-21. Applicant: Ningbo Diaier Electronic Co., Ltd..

Clearance details

Applicant: Ningbo Diaier Electronic Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-05-27
Decision date: 2009-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuyao City, Zhejiang, CN

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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.