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FDA 510(k), K150245, CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
FDA 510(k), K150245, CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
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510(K) Number: K150245
Device Name: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
Manufacturer: GE HEALTHCARE FINLAND OY
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 02/02/2015
Decision Date: 07/17/2015
Regulation Medical Specialty: Anesthesiology
Device Name: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
Manufacturer: GE HEALTHCARE FINLAND OY
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 02/02/2015
Decision Date: 07/17/2015
Regulation Medical Specialty: Anesthesiology
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