PERFUSION MONITOR

Sensor, Blood-gas, In-line, Cardiopulmonary Bypass

CARDIO METRICS, INC.

The following data is part of a premarket notification filed by Cardio Metrics, Inc. with the FDA for Perfusion Monitor.

Pre-market Notification Details

Device IDK900860
510k NumberK900860
Device Name:PERFUSION MONITOR
ClassificationSensor, Blood-gas, In-line, Cardiopulmonary Bypass
Applicant CARDIO METRICS, INC. 525 JULIE RIVERS DR. STE.100 Sugar Land,  TX  77478
ContactR Wilkinson
CorrespondentR Wilkinson
CARDIO METRICS, INC. 525 JULIE RIVERS DR. STE.100 Sugar Land,  TX  77478
Product CodeDTY  
CFR Regulation Number870.4410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-23
Decision Date1990-08-14

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