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FDA 510(k), K152402, IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
FDA 510(k), K152402, IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
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$149.00 USD
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$149.00 USD
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510(K) Number: K152402
Device Name: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
Manufacturer: William J Gorman
Device Classification Name: Thermometer, Electronic, Clinical
Regulation Number: FLL
Classification Product Code: 08/25/2015
Date Received: 03/04/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
Manufacturer: William J Gorman
Device Classification Name: Thermometer, Electronic, Clinical
Regulation Number: FLL
Classification Product Code: 08/25/2015
Date Received: 03/04/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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