LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

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 2nd Generation Centrimag Primary Console, Levitronix Monitor.

Pre-market Notification Details

Device IDK102129
510k NumberK102129
Device Name:LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
ContactFarzad Parsaie
CorrespondentFarzad Parsaie
LEVITRONIX LLC. 45 FIRST AVE. Waltham,  MA  02451
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-29
Decision Date2010-08-27
Summary:summary

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