510(k) Premarket Notification

• Device Classification Name: thermometer, electronic, clinical
• 510(k) Number: K152402
• FOIA Releasable 510(k): K152402
• Device Name: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
• Applicant: SECURUS,INC; 100 Cummings Center; Suite 215F; Beverly, MA 01915
• Applicant Contact: William J Gorman
• Correspondent: SECURUS,INC; 100 Cummings Center; Suite 215F; Beverly, MA 01915
• Correspondent Contact: William J Gorman
• Regulation Number: 880.2910
• Classification Product Code: FLL
• Subsequent Product Code: LHQ
• Date Received: 08/25/2015
• Decision Date: 03/04/2016
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General Hospital
• Summary: Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No