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510(k) K203695

NObreath® by Bedfont Scientific, Ltd. — Product Code MXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2021
Date Received
December 18, 2020
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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  • K000962 — PICO SMOKERLYZER, MODEL EC-50 (April 20, 2000)

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  • K133898 — NIOX VERO AIRWAY INFLAMMATION MONITOR (November 6, 2014)
  • K123683 — NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR (December 27, 2012)
  • K101034 — NIOX MINO MODEL 09-1000 (September 2, 2010)