ION HEALTH USB INSTA-SCAN THERMOMETER— 510(k) K111974

Substantially Equivalent

Taidoc Technology Corporation

FDA 510(k) clearance K111974 for ION HEALTH USB INSTA-SCAN THERMOMETER, Substantially Equivalent on 2011-08-15. Applicant: Taidoc Technology Corporation.

Clearance details

Applicant: Taidoc Technology Corporation
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2011-07-12
Decision date: 2011-08-15
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei 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.