M4 MONITOR

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

SPECTRUM MEDICAL, LLP

The following data is part of a premarket notification filed by Spectrum Medical, Llp with the FDA for M4 Monitor.

Pre-market Notification Details

Device IDK110957
510k NumberK110957
Device Name:M4 MONITOR
ClassificationMonitor, Blood-gas, On-line, Cardiopulmonary Bypass
Applicant SPECTRUM MEDICAL, LLP CHELTENHAM ROAD EAST Gloucester,  GB Gl2 9ql
ContactSteve Turner
Product CodeDRY  
CFR Regulation Number870.4330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-04-05
Decision Date2011-05-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060434420206 K110957 000
05060434420190 K110957 000
05060434420183 K110957 000
05060434420176 K110957 000
05060434420169 K110957 000
05060434420152 K110957 000
05060434420046 K110957 000

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