IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)— 510(k) K152402

Substantially Equivalent

Securus,Inc

FDA 510(k) clearance K152402 for IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU), Substantially Equivalent on 2016-03-04. Applicant: Securus,Inc.

Clearance details

Applicant: Securus,Inc
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2015-08-25
Decision date: 2016-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
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.