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510(k) K151982

Stat Profile Prime ABG Analyzer System by Nova Biomedical Corporation — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2015
Date Received
July 17, 2015
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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