K162137

Substantially Equivalent

Fever Scout Continuous Monitoring thermometer

Applicant: VivaLNK, Inc.
Product code: FLL
Advisory panel: General Hospital
Date received: 2016-08-01
Decision date: 2017-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, 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.