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Blood Establishment Computer Software And Accessories

Cerner Corporation

The following data is part of a premarket notification filed by Cerner Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK060037
510k NumberBK060037
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationBlood Establishment Computer Software And Accessories
Applicant Cerner Corporation 2800 Rock Creek Parkway Kansas City,  MO  64117 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-03
Decision Date2007-05-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853023006104 BK060037 0

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