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510(k) K073265

APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM by Apieron, Inc. — Product Code MXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2008
Date Received
November 20, 2007
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

Other clearances by Apieron, Inc.

  • K083617 — APIERON INSIGHT ENO SYSTEM (January 27, 2009)

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