IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081— 510(k) K100488

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K100488 for IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081, Substantially Equivalent on 2010-07-22. Applicant: Shenzhen Dongdixin Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-02-19
Decision date: 2010-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanshan District, 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.