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510(k) K203790

GEM Premier 5000 by Instrumentation Laboratory CO — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2021
Date Received
December 28, 2020
Clearance Type
Special
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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