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510(k) K123748

ABL90 FLEX by Radiometer Medical Aps — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2013
Date Received
December 6, 2012
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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