The following data is part of a premarket notification filed by Aerocrine Ab with the FDA for Niox Mino Model 09-1000.
| Device ID | K101034 |
| 510k Number | K101034 |
| Device Name: | NIOX MINO MODEL 09-1000 |
| Classification | System, Test, Breath Nitric Oxide |
| Applicant | AEROCRINE AB SUNDBYBERGSVAGEN 9 P.O. BOX 1024 Solna, SE Se-17121 |
| Contact | Johanna Karling |
| Correspondent | Johanna Karling AEROCRINE AB SUNDBYBERGSVAGEN 9 P.O. BOX 1024 Solna, SE Se-17121 |
| Product Code | MXA |
| CFR Regulation Number | 862.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350047030038 | K101034 | 000 |
| 07350047030120 | K101034 | 000 |
| 07350047030168 | K101034 | 000 |
| 07350047030113 | K101034 | 000 |
| 07350047030106 | K101034 | 000 |
| 07350047030076 | K101034 | 000 |
| 07350047030069 | K101034 | 000 |
| 07350047030052 | K101034 | 000 |