ABL90 FLEX

Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

RADIOMETER MEDICAL APS

The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Abl90 Flex.

Pre-market Notification Details

Device IDK122642
510k NumberK122642
Device Name:ABL90 FLEX
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj,  DK Dk-2700
ContactMartin Gabler
CorrespondentMartin Gabler
RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj,  DK Dk-2700
Product CodeCHL  
Subsequent Product CodeCEM
Subsequent Product CodeCGA
Subsequent Product CodeCGZ
Subsequent Product CodeGHS
Subsequent Product CodeGKR
Subsequent Product CodeJFP
Subsequent Product CodeJGS
Subsequent Product CodeJIX
Subsequent Product CodeJJY
Subsequent Product CodeKHP
Subsequent Product CodeKQI
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-29
Decision Date2012-10-26
Summary:summary

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