ATS Thermal Imaging Probe, ATS Patient Interface Unit— 510(k) K180148

Substantially Equivalent

Securus Medical Group, Inc.

FDA 510(k) clearance K180148 for ATS Thermal Imaging Probe, ATS Patient Interface Unit, Substantially Equivalent on 2018-03-21. Applicant: Securus Medical Group, Inc..

Clearance details

Applicant: Securus Medical Group, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2018-01-19
Decision date: 2018-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Beverly, 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.