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510(k) K173403

GEM Premier 5000 by Instrumentation Laboratory CO — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2017
Date Received
October 31, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

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