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510(k) K142898

ABL800 FLEX with AQURE connectivity by Radiometer Medical Aps — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2015
Date Received
October 6, 2014
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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