RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES— 510(k) K030324

Substantially Equivalent

Radiant Innovation, Inc.

FDA 510(k) clearance K030324 for RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES, Substantially Equivalent on 2003-02-27. Applicant: Radiant Innovation, Inc..

Clearance details

Applicant: Radiant Innovation, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-01-31
Decision date: 2003-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu City, TW

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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.