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Blood Establishment Computer Software And Accessories

Epic Systems Corporation

The following data is part of a premarket notification filed by Epic Systems 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 IDBK170032
510k NumberBK170032
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 Epic Systems Corporation 1979 Milky Way Verona,  WI  53593
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-03
Decision Date2017-06-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860475000345 BK170032 0

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