510(k) K170662— Non Contact Infrared Forehead Thermometer

Substantially Equivalent

Intrinity Global Limited

Clearance details

Applicant: Intrinity Global Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2017-03-03
Decision date: 2017-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

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.