System, Processing For Frozen Blood

Device Code: 2405

Product Code(s): KSW

Device Classification Information

Device Type ID2405
Device NameSystem, Processing For Frozen Blood
Regulation DescriptionProcessing System For Frozen Blood.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(k)
CFR Regulation Number864.9145 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKSW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2405
DeviceSystem, Processing For Frozen Blood
Product CodeKSW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionProcessing System For Frozen Blood.
CFR Regulation Number864.9145 [🔎]
Premarket Reviews
ManufacturerDecision
FRESENIUS
 
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS KABI AG
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Leak / Splash
2
Noise, Audible
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 20:11:17

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