NC° Thermometer (Gen 3), Model Number: NCTG3— 510(k) K223522

Substantially Equivalent

Xiamen Intretech, Inc.

FDA 510(k) clearance K223522 for NC° Thermometer (Gen 3), Model Number: NCTG3, Substantially Equivalent on 2023-06-20. Applicant: Xiamen Intretech, Inc..

Clearance details

Applicant: Xiamen Intretech, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2022-11-23
Decision date: 2023-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.