510(k) K172870— Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J

Substantially Equivalent

Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

Clearance details

Applicant: Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2017-09-20
Decision date: 2018-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Hangzhou, 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.