510(k) K181270— Disposable SpO2 Sensors, Reusable SpO2 Sensors

Substantially Equivalent

Orantech, Inc.

Clearance details

Applicant: Orantech, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2018-05-14
Decision date: 2018-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.