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510(k) K203695

Device
NObreath®
Applicant
Bedfont Scientific Ltd
510(k) number
K203695
Product code
MXA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-17
Date received
2020-12-18
Regulation
862.3080
Classification name
System, Test, Breath Nitric Oxide
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Louise Bateman
Address
Station Rd., Harrietsham Maidstone, Kent GB ME17 1JA ME17 1JA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MXA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation2025-11-26
K243926Vivatmo pro-SBosch Healthcare Solutions GmbH2025-09-11
K233775Vivatmo proBosch Healthcare Solutions GmbH2024-02-22
K213611Fenom ProCaire Diagnostics, Inc.2023-06-07
K182874Fenom Pro Nitric Oxide TestSpirosure, Inc.2019-02-13
K170983NIOX VEROCircassia AB2017-11-22
K150233NIOX VERO Airway Inflammation MonitorAerocrine AB2015-02-26
K133898NIOX VERO AIRWAY INFLAMMATION MONITORAerocrine AB2014-11-06
K123683NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITORAerocrine AB2012-12-27
K101034NIOX MINO MODEL 09-1000Aerocrine AB2010-09-02
K083617APIERON INSIGHT ENO SYSTEMApieron, Inc.2009-01-27
K073265APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEMApieron, Inc.2008-03-14
K072816NIOX MINOAerocrine AB2008-03-03
DEN030001NIOX ARTICLE NO: 02-1000Aerocrine AB2003-04-30

Legacy Summary#

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FDA Review#

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