GAST STAT MONITORING SYSTEM

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

CARDIOVASCULAR DEVICES, INC.

The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Gast Stat Monitoring System.

Pre-market Notification Details

Device IDK840749
510k NumberK840749
Device Name:GAST STAT MONITORING SYSTEM
ClassificationSensor, Blood-gas, In-line, Cardiopulmonary Bypass
Applicant CARDIOVASCULAR DEVICES, INC. CA 
Product CodeDTY  
CFR Regulation Number870.4410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-23
Decision Date1984-04-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.