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510(k) K160153

ABL90 FLEX PLUS by Radiometer Medical Aps — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2016
Date Received
January 22, 2016
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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