K211744

Substantially Equivalent

Non-Contact Infrared Thermometer, model HL710H

Applicant: Health & Life Co., Ltd.
Product code: FLL
Advisory panel: General Hospital
Date received: 2021-06-07
Decision date: 2021-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei, TW

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.