IR FOREHEAD THERMOMETER, MODEL HV-T36— 510(k) K032612

Substantially Equivalent

Oriental Inspiration, Ltd.

FDA 510(k) clearance K032612 for IR FOREHEAD THERMOMETER, MODEL HV-T36, Substantially Equivalent on 2004-02-19. Applicant: Oriental Inspiration, Ltd..

Clearance details

Applicant: Oriental Inspiration, Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-08-25
Decision date: 2004-02-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Alpharetta, GA, US

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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.