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IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

K152402 Class II Traditional
Decision Date
2016-03-04
Sponsor / Applicant
Securus,Inc

Technical Specification

510(k) Submission ID K152402
Product Code FLL
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.2910
Decision Date 2016-03-04
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) received FDA 510(k) clearance under submission number K152402, sponsored by Securus,Inc. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-03-04.

Classification & Regulation

This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.