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Blood Establishment Computer Software And Accessories

MEDITECH Medical Information Technology, Inc.

The following data is part of a premarket notification filed by Meditech Medical Information Technology, 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 IDBK080037
510k NumberBK080037
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 MEDITECH Medical Information Technology, Inc. meditech Circle Westwood,  MA  02090 US
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-30
Decision Date2008-10-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863529000117 BK080037 0

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