Quantum Ventilation Module

Gas Control Unit, Cardiopulmonary Bypass

Spectrum Medical Ltd

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

Pre-market Notification Details

Device IDK202733
510k NumberK202733
Device Name:Quantum Ventilation Module
ClassificationGas Control Unit, Cardiopulmonary Bypass
Applicant Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester,  GB Gl2 9ql
ContactColleen Powell
CorrespondentColleen Powell
Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester,  GB Gl2 9ql
Product CodeDTX  
CFR Regulation Number870.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-18
Decision Date2020-10-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060434422743 K202733 000
05060434422736 K202733 000
05060434422071 K202733 000
05060434422064 K202733 000
05060434422859 K202733 000
05060434422842 K202733 000
05060434422699 K202733 000
15060434423815 K202733 000
05060434421906 K202733 000

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