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Blood Establishment Computer Software And Accessories

CPSI

The following data is part of a premarket notification filed by Cpsi 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 IDBK130003
510k NumberBK130003
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 CPSI 6600 Wall Street Mobile,  AL  36695
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Abbrevia
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-15
Decision Date2014-04-30

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