SATURATION/HEMATOCRIT MONITOR SYSTEM

Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Saturation/hematocrit Monitor System.

Pre-market Notification Details

Device IDK910421
510k NumberK910421
Device Name:SATURATION/HEMATOCRIT MONITOR SYSTEM
ClassificationMonitor, Blood-gas, On-line, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim,  CA  92807
ContactNorma Lowe
CorrespondentNorma Lowe
MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim,  CA  92807
Product CodeDRY  
CFR Regulation Number870.4330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-30
Decision Date1991-10-15

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