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510(k) K223608

GEM Premier 7000 with IQM3 by Instrumentation Laboratory Company — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2023
Date Received
December 2, 2022
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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