Pulse Oximeter (Model C101A2, C101B1, C101A3)— 510(k) K221979

Substantially Equivalent

Shenzhen Imdk Medical Technology Co., Ltd.

FDA 510(k) clearance K221979 for Pulse Oximeter (Model C101A2, C101B1, C101A3), Substantially Equivalent on 2022-10-16. Applicant: Shenzhen Imdk Medical Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Imdk Medical Technology Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2022-07-05
Decision date: 2022-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, 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.