Blood Establishment Computer Software And Accessories

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 Blood Establishment Computer Software And Accessories.

Pre-market Notification Details

Device IDBK210556
510k NumberBK210556
Device Name:Blood Establishment Computer Software And Accessories
ClassificationBlood Establishment Computer Software And Accessories
Applicant Sunquest Information Systems, Inc. 3330 East Sunrise Dr Tucson,  AZ  85718
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-19
Decision Date2021-04-16

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