The following data is part of a premarket notification filed by Aerocrine Ab with the FDA for Niox Panel For Use With The Niox Mino Airway Inflammation Monitor.
| Device ID | K123683 |
| 510k Number | K123683 |
| Device Name: | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | AEROCRINE AB SUNDBYBERGSVAGEN 9 Solna, SE 17173 |
| Contact | Kathleen Rickard, Md |
| Correspondent | Kathleen Rickard, Md AEROCRINE AB SUNDBYBERGSVAGEN 9 Solna, SE 17173 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-30 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350047030519 | K123683 | 000 |