DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER— 510(k) K041694

Substantially Equivalent

Hangzhou Hua'An Medical & Health Instruments Co.,

FDA 510(k) clearance K041694 for DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER, Substantially Equivalent on 2004-09-13. Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,.

Clearance details

Applicant
Hangzhou Hua'An Medical & Health Instruments Co.,
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou, Zhejiang, 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.