DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.— 510(k) K072641

Substantially Equivalent

Famidoc Technology Co., Ltd.

FDA 510(k) clearance K072641 for DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4., Substantially Equivalent on 2007-11-01. Applicant: Famidoc Technology Co., Ltd..

Clearance details

Applicant
Famidoc Technology Co., Ltd.
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen Guangdong,Pr, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

Source: openFDA MAUDE database, through . 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.