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Blood Establishment Computer Software And Accessories

Mediware Information Systems, Inc.

The following data is part of a premarket notification filed by Mediware 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 IDBK180200
510k NumberBK180200
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 Mediware Information Systems, Inc. 11711 West 79th St Lenexa,  KS  66214 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-04
Decision Date2018-07-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B105BLOODCENTERS2019 BK180200 0
B105BLOODCENTERS0 BK180200 0
B105BLOODCENTERS2023 BK180200 0
B105BLOODCENTERS2018 BK180200 0
B10520241 BK180200 0

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