Quantum Heater-Cooler

Controller, Temperature, Cardiopulmonary Bypass

Spectrum Medical Ltd.

The following data is part of a premarket notification filed by Spectrum Medical Ltd. with the FDA for Quantum Heater-cooler.

Pre-market Notification Details

Device IDK212657
510k NumberK212657
Device Name:Quantum Heater-Cooler
ClassificationController, Temperature, Cardiopulmonary Bypass
Applicant Spectrum Medical Ltd. Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester,  GB Gl29ql
ContactColleen Powell
Product CodeDWC  
CFR Regulation Number870.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2022-05-06
Summary:summary

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