GEM Premier 5000

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

Instrumentation Laboratory Co.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 5000.

Pre-market Notification Details

Device IDK203790
510k NumberK203790
Device Name:GEM Premier 5000
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
ContactGabriella Erdosy
CorrespondentGabriella Erdosy
Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
Product CodeCHL  
Subsequent Product CodeCEM
Subsequent Product CodeCGA
Subsequent Product CodeCGZ
Subsequent Product CodeGHS
Subsequent Product CodeGKF
Subsequent Product CodeGKR
Subsequent Product CodeGLY
Subsequent Product CodeJFP
Subsequent Product CodeJGS
Subsequent Product CodeKHP
Subsequent Product CodeMQM
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-08-20

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.