NO TOUCH+FOREHEAD NTF 3000 THERMOMETER— 510(k) K134043

Substantially Equivalent

Kaz USA, Inc (A Subsidiaryof Kaz Inc)

FDA 510(k) clearance K134043 for NO TOUCH+FOREHEAD NTF 3000 THERMOMETER, Substantially Equivalent on 2014-05-21. Applicant: Kaz USA, Inc (A Subsidiaryof Kaz Inc).

Clearance details

Applicant: Kaz USA, Inc (A Subsidiaryof Kaz Inc)
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2013-12-31
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.