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Blood Establishment Computer Software And Accessories

Terumo BCT, Inc

The following data is part of a premarket notification filed by Terumo Bct, Inc 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 IDBK070001
510k NumberBK070001
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 Terumo BCT, Inc 10811 W. Collins Ave. Lakewood,  CO  80215 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-22
Decision Date2007-06-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05020583252035 BK070001 0
05020583252028 BK070001 0
05020583252011 BK070001 0

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