M3 MONITOR

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 M3 Monitor.

Pre-market Notification Details

Device IDK091908
510k NumberK091908
Device Name:M3 MONITOR
ClassificationMonitor, Blood-gas, On-line, Cardiopulmonary Bypass
Applicant SPECTRUM MEDICAL LTD HARRIER 4,METEOR BUSINESS PARK CHELTENHAM ROAD EAST Gloucester, Gloucesterhsire,  GB Gl2 9ql
ContactSteve Turner
CorrespondentJeff D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeDRY  
CFR Regulation Number870.4330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-06-25
Decision Date2009-07-10
Summary:summary

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