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

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 IDBK160066
510k NumberBK160066
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 Received2016-07-05
Decision Date2016-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B105TRANSFUSION20180 BK160066 0
B105TRANSFUSION20190 BK160066 0
B105TRANSFUSION2021 BK160066 0
B105TRANSFUSION2020 BK160066 0
B105TRANSFUSION0 BK160066 0
B105HCLL0 BK160066 0

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.