Blood Establishment Computer Software And Accessories

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 Blood Establishment Computer Software And Accessories.

Pre-market Notification Details

Device IDBK200517
510k NumberBK200517
Device Name:Blood Establishment Computer Software And Accessories
ClassificationBlood Establishment Computer Software And Accessories
Applicant Biomat USA, Inc. 2410 Lillyvale Ave Los Angeles,  CA  90032
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2020-11-05

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