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510(k) K170983

NIOX VERO by Circassia AB — Product Code MXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2017
Date Received
April 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Breath Nitric Oxide
Device Class
Class II
Regulation Number
862.3080
Review Panel
CH
Submission Type

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