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Blood Establishment Computer Software And Accessories

GE Medical Information Technologies

The following data is part of a premarket notification filed by Ge Medical Information Technologies 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 IDBK050018
510k NumberBK050018
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 GE Medical Information Technologies 540 Northwest Highway Barrington,  IL  60010
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Abbrevia
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-23
Decision Date2005-06-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060508820000 BK050018 0

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