K082641

Substantially Equivalent

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL

Applicant: Contec Medical System Co., Ltd.
Product code: DQA
Advisory panel: Cardiovascular
Date received: 2008-09-11
Decision date: 2008-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Zhong Shan, Shanghai, 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.