REMOTE INFRARED THERMOMETER, MODEL RC002— 510(k) K090361

Substantially Equivalent

Rycom Electron Technology Limited

FDA 510(k) clearance K090361 for REMOTE INFRARED THERMOMETER, MODEL RC002, Substantially Equivalent on 2009-10-08. Applicant: Rycom Electron Technology Limited.

Clearance details

Applicant: Rycom Electron Technology Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2009-02-12
Decision date: 2009-10-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.