510(k) K152975— VDT985US Vicks SmartTemp Thermometer

Substantially Equivalent

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: 2015-10-08
Decision date: 2016-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

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.