510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MXAClass II

System, Test, Breath Nitric Oxide

21 CFR 862.3080 / Clinical Toxicology
FDA source (opens on fda.gov)

MXA is the FDA product code for System, Test, Breath Nitric Oxide, a class II device type, regulated under 21 CFR 862.3080. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MXA
Device name
System, Test, Breath Nitric Oxide
Regulation
21 CFR 862.3080
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
1

Clearances, product code MXA

By decision year
15 clearances under product code MXA with a decision year between 2003 and 2025, 2008 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MXA by decision year
YearClearances
20031
20082
20091
20101
20121
20141
20151
20171
20191
20211
20231
20241
20252

Applicants with the most clearances

Product code MXA
Applicants holding the most 510(k) clearances under product code MXA
ApplicantClearances
Aerocrine AB6
Apieron, Inc.2
Bosch Healthcare Solutions GmbH2
Bedfont Scientific Ltd.1
Caire Diagnostics, Inc.1
Circassia AB1
Mgc Diagnostics Corporation1
Spirosure, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code