GAMBRO BICARBONATE MODULE, BCM-10

Subsystem, Proportioning

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Bicarbonate Module, Bcm-10.

Pre-market Notification Details

Device IDK810127
510k NumberK810127
Device Name:GAMBRO BICARBONATE MODULE, BCM-10
ClassificationSubsystem, Proportioning
Applicant GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKR  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-19
Decision Date1981-02-25

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