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510(k) K110416

ABL835 FLEX ANALYZER WITH PLEURAL PH by Radiometer Medical Aps — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2011
Date Received
February 14, 2011
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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