INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22— 510(k) K063291

Substantially Equivalent

Choice Smart Health Care Co. , Ltd.

FDA 510(k) clearance K063291 for INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22, Substantially Equivalent on 2006-11-21. Applicant: Choice Smart Health Care Co. , Ltd..

Clearance details

Applicant: Choice Smart Health Care Co. , Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2006-11-01
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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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.