Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)— 510(k) K243049

Substantially Equivalent

Hunan Accurate Bio-Medical Technology Co., Ltd.

FDA 510(k) clearance K243049 for Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C), Substantially Equivalent on 2025-01-02. Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd..

Clearance details

Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2024-09-27
Decision date: 2025-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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.