3M CDI BLOOD PARAMETER MONITORING SYSTEM 500

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

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Cdi Blood Parameter Monitoring System 500.

Pre-market Notification Details

Device IDK972962
510k NumberK972962
Device Name:3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
ClassificationMonitor, Blood-gas, On-line, Cardiopulmonary Bypass
Applicant 3M COMPANY 1311 VALENCIA AVE. Tustin,  CA  92680
ContactAnne Buteyn
CorrespondentAnne Buteyn
3M COMPANY 1311 VALENCIA AVE. Tustin,  CA  92680
Product CodeDRY  
CFR Regulation Number870.4330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-11
Decision Date1997-11-06
Summary:summary

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