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510(k) K083617

APIERON INSIGHT ENO SYSTEM by Apieron, Inc. — Product Code MXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2009
Date Received
December 8, 2008
Clearance Type
Special
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.

  • K073265 — APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM (March 14, 2008)

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