THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F— 510(k) K013779

Substantially Equivalent

Mesure Technology

FDA 510(k) clearance K013779 for THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F, Substantially Equivalent on 2002-03-29. Applicant: Mesure Technology.

Clearance details

Applicant
Mesure Technology
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Acton, CA, 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.