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Blood Establishment Computer Software And Accessories

Sunquest Information Systems, Inc.

The following data is part of a premarket notification filed by Sunquest Information Systems, 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 IDBK160005
510k NumberBK160005
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 Sunquest Information Systems, Inc. 250 S. Williams Blvd. Tucson,  AZ  85711
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-27
Decision Date2016-03-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B236BB10000 BK160005 0
B236BB11020 BK160005 0
B236BB11010 BK160005 0
B236BB11000 BK160005 0
B236BB10110 BK160005 0
B236BB10100 BK160005 0
B236BB10010 BK160005 0
B236BB8010 BK160005 0
B236BB8130 BK160005 0
B236BB8230 BK160005 0
B236SQBB11030 BK160005 0

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