NIOX MINO
System, Test, Breath Nitric Oxide
AEROCRINE AB
The following data is part of a premarket notification filed by Aerocrine Ab with the FDA for Niox Mino.
Pre-market Notification Details
| Device ID | K072816 |
| 510k Number | K072816 |
| Device Name: | NIOX MINO |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | AEROCRINE AB 801 PENNSYLVANIA AVE. Washington, DC 20004 |
| Contact | Joel Slomoff |
| Correspondent | Joel Slomoff AEROCRINE AB 801 PENNSYLVANIA AVE. Washington, DC 20004 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-02 |
| Decision Date | 2008-03-03 |
| Summary: | summary |
Trademark Results [NIOX MINO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIOX MINO 79006882 3066160 Live/Registered |
Circassia AB 2004-07-20 |
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