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Blood Establishment Computer Software And Accessories

Wyndgate Technologies

The following data is part of a premarket notification filed by Wyndgate 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 IDBK070064
510k NumberBK070064
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 Wyndgate Technologies 4925 Robert J. Matthews Parkway suite 100 El Dorado Hills,  CA  95762
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-19
Decision Date2008-02-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812747010132 BK070064 0

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