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510(k) K213611

Fenom Pro by Caire Diagnostics, Inc. — Product Code MXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2023
Date Received
November 15, 2021
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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