FDA.reportPublic FDA data

510(k) DEN030001

Device
NIOX ARTICLE NO: 02-1000
Applicant
Aerocrine AB
510(k) number
DEN030001
Product code
MXA
Decision
Unknown (DENG)
Decision date
2003-04-30
Date received
2003-03-18
Regulation
862.3080
Classification name
System, Test, Breath Nitric Oxide
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Post-NSE
Third party reviewed
N

Applicant Contact#

Contact
SEAN M CURRY
Address
16787 Bernardo Center Dr., Suite A-1 San Diego CA US 92128 92128

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K203695NObreath®Bedfont Scientific, Ltd.2021-12-17
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