PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1— 510(k) K111617

Substantially Equivalent

Acare Technology Co., Ltd.

FDA 510(k) clearance K111617 for PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1, Substantially Equivalent on 2011-12-22. Applicant: Acare Technology Co., Ltd..

Clearance details

Applicant: Acare Technology Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2011-06-10
Decision date: 2011-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.