E-Z THERM 3 SECOND THERMOMETER— 510(k) K932204

Substantially Equivalent

North American Technical Services Corp.

FDA 510(k) clearance K932204 for E-Z THERM 3 SECOND THERMOMETER, Substantially Equivalent on 1994-10-03. Applicant: North American Technical Services Corp..

Clearance details

Applicant
North American Technical Services Corp.
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sound Beach, NY, 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.