Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711— 510(k) K210565

Substantially Equivalent

Alicn Medical Shenzhen, Inc.

FDA 510(k) clearance K210565 for Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711, Substantially Equivalent on 2022-05-05. Applicant: Alicn Medical Shenzhen, Inc..

Clearance details

Applicant: Alicn Medical Shenzhen, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2021-02-25
Decision date: 2022-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, 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.