|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
gem premier 5000
|
Instrumentation Laboratory Co.
|
K203790 |
08/20/2021
|
gem premier chemstat
|
Instrumentation Laboratory Co.
|
K183546 |
02/16/2019
|
gem premier 5000
|
Instrumentation Laboratory Co.
|
K173403 |
12/29/2017
|
gem premier 5000 (measured parameters: ph, pco2 and po2)
|
Instrumentation Laboratory Co.
|
K160412 |
12/14/2016
|
gem premier 3000
|
Instrumentation Laboratory Co.
|
K161818 |
09/14/2016
|
gem premier 4000
|
INSTRUMENTATION LABORATORY CO.
|
K133407 |
01/13/2014
|
gem premier 4000
|
INSTRUMENTATION LABORATORY CO.
|
K112995 |
05/03/2012
|
gem premier 4000 with iqm, model 4000; gem cvp 1 and 2 with co-ox; gem cvp 3 and 4 hematocrit
|
INSTRUMENTATION LABORATORY CO.
|
K061974 |
09/15/2006
|
gem premier 3000
|
INSTRUMENTATION LABORATORY CO.
|
K992834 |
11/24/1999
|
il synthesis
|
INSTRUMENTATION LABORATORY CO.
|
K963800 |
11/13/1996
|