FDA 510(k), K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor

FDA 510(k), K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor

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510(K) Number: K182868
Device Name: INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Manufacturer: Samir Ibrahim
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 10/12/2018
Date Received: 01/08/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

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