Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311— 510(k) K212257

Substantially Equivalent

Alicn Medical Shenzhen, Inc.

FDA 510(k) clearance K212257 for Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311, Substantially Equivalent on 2022-05-04. Applicant: Alicn Medical Shenzhen, Inc..

Clearance details

Applicant: Alicn Medical Shenzhen, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2021-07-19
Decision date: 2022-05-04
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.