Blood Mixing And Weighing Devices

Device, Blood Mixing And Blood Weighing

Fresenius Medical Care North America

The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Blood Mixing And Weighing Devices.

Pre-market Notification Details

Device IDBK040005
510k NumberBK040005
Device Name:Blood Mixing And Weighing Devices
ClassificationDevice, Blood Mixing And Blood Weighing
Applicant Fresenius Medical Care North America 95 Hayden Avenue Lexington,  MA  02420 US
Product CodeKSQ  
CFR Regulation Number864.9195 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-29
Decision Date2004-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04086000860765 BK040005 0
04086000860758 BK040005 0
04086000860741 BK040005 0

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