ETCO2 Sensor— 510(k) K171828

Substantially Equivalent

Orantech, Inc.

FDA 510(k) clearance K171828 for ETCO2 Sensor, Substantially Equivalent on 2018-05-31. Applicant: Orantech, Inc..

Clearance details

Applicant: Orantech, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2017-06-20
Decision date: 2018-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.