Quantum Workstation 12 Elite

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

Spectrum Medical Ltd

The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Workstation 12 Elite.

Pre-market Notification Details

Device IDK202557
510k NumberK202557
Device Name:Quantum Workstation 12 Elite
ClassificationMonitor, Blood-gas, On-line, 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 CodeDRY  
CFR Regulation Number870.4330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-03
Decision Date2020-10-02

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