DIGITAL THERMOMETER; DIGITAL THERMOMETER— 510(k) K102718

Substantially Equivalent

International Regulatory Consultants, LLC (Irc)

FDA 510(k) clearance K102718 for DIGITAL THERMOMETER; DIGITAL THERMOMETER, Substantially Equivalent on 2010-12-13. Applicant: International Regulatory Consultants, LLC (Irc).

Clearance details

Applicant: International Regulatory Consultants, LLC (Irc)
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-09-21
Decision date: 2010-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, CN

Download summary PDF View on FDA.gov ↗

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.