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Blood Establishment Computer Software And Accessories

Biomat USA, Inc.

The following data is part of a premarket notification filed by Biomat Usa, 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 IDBK090082
510k NumberBK090082
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 Biomat USA, Inc. 1311 Temple Avenue City Of Industry,  CA  91746
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-07
Decision Date2010-10-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817955020010 BK090082 0

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