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

SCC Soft Computer

The following data is part of a premarket notification filed by Scc Soft Computer 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 IDBK100045
510k NumberBK100045
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 SCC Soft Computer 5400 Tech Data Drive Clearwater,  FL  33760
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-12
Decision Date2010-07-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859474006281 BK100045 0
00859474006113 BK100045 0
00859474006014 BK100045 0
00859474006007 BK100045 0

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