K240808

Substantially Equivalent

Pulse Oximeter (WS20A)

Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
Product code: DQA
Advisory panel: Cardiovascular
Date received: 2024-03-25
Decision date: 2024-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.