IRTS Thermal Imaging Probe (TIP); IRTS Patient Monitoring Unit (PMU); IRTS Patient Interface Unit (PIU)— 510(k) K152402
Substantially EquivalentSecurus,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. Device class: 2.
Clearance details
- Device name as filed
- IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
- Applicant
- Securus,Inc
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
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Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
Source: openFDA MAUDE database, through . 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.