FLEXIBLE TIP THERMOMETER, MODEL 011206— 510(k) K030673

Substantially Equivalent

Global Treasure Industries , Ltd.

FDA 510(k) clearance K030673 for FLEXIBLE TIP THERMOMETER, MODEL 011206, Substantially Equivalent on 2003-04-04. Applicant: Global Treasure Industries , Ltd..

Clearance details

Applicant
Global Treasure Industries , Ltd.
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beverly, MA, US
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.