Panels › Clinical Toxicology › Product code MXA · Class 2
System, Test, Breath Nitric Oxide
Regulation 862.3080
1510(k)s in 12 months (15 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MXA
| Company | 510(k)s | Recalls |
|---|---|---|
| Aerocrine AB | 6 | 0 |
| Apieron, Inc. | 2 | 0 |
| Bosch Healthcare Solutions GmbH | 2 | 0 |
| Caire Diagnostics, Inc. | 1 | 1 |
| Bedfont Scientific, Ltd. | 1 | 0 |
| Circassia AB | 1 | 0 |
| Mgc Diagnostics Corporation | 1 | 0 |
| Spirosure, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2021 | CAIRE DIAGNOSTICS INC CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in cri Terminated |
MXA | K182874 |
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