Quantum Workstation 12.1

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 12.1.

Pre-market Notification Details

Device IDK181923
510k NumberK181923
Device Name:Quantum Workstation 12.1
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 Received2018-07-18
Decision Date2018-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060434420718 K181923 000

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