Vicks VNT200 No Touch Forehead Thermometer— 510(k) K193213

Substantially Equivalent

Kaz USA, Inc., A Helen of Troy Company

FDA 510(k) clearance K193213 for Vicks VNT200 No Touch Forehead Thermometer, Substantially Equivalent on 2020-04-28. Applicant: Kaz USA, Inc., A Helen of Troy Company.

Clearance details

Applicant: Kaz USA, Inc., A Helen of Troy Company
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2019-11-21
Decision date: 2020-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, 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.