LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES

Control, Pump Speed, Cardiopulmonary Bypass

LEVITRONIX LLC.

The following data is part of a premarket notification filed by Levitronix Llc. with the FDA for Levitronix Centrimag Primary And Backup Consoles.

Pre-market Notification Details

Device IDK093832
510k NumberK093832
Device Name:LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
ContactSusan K Hamann
CorrespondentSusan K Hamann
LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-14
Decision Date2010-01-13
Summary:summary

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