The following data is part of a premarket notification filed by Nox Medical with the FDA for Nox T3, Noxturnal (pc Application).
| Device ID | K082113 |
| 510k Number | K082113 |
| Device Name: | NOX T3, NOXTURNAL (PC APPLICATION) |
| Classification | Ventilatory Effort Recorder |
| Applicant | NOX MEDICAL KELDNAHOLTI Reykjavik, IS 112 |
| Contact | Kolbrun E Ottosdottir |
| Correspondent | Kolbrun E Ottosdottir NOX MEDICAL KELDNAHOLTI Reykjavik, IS 112 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-28 |
| Decision Date | 2008-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15694311111443 | K082113 | 000 |
| 15694311110064 | K082113 | 000 |
| 15694311110088 | K082113 | 000 |
| 15694311110255 | K082113 | 000 |
| 15694311110460 | K082113 | 000 |
| 15694311110477 | K082113 | 000 |
| 15694311110712 | K082113 | 000 |
| 15694311110842 | K082113 | 000 |
| 15694311110927 | K082113 | 000 |
| 15694311111405 | K082113 | 000 |
| 15694311111412 | K082113 | 000 |
| 15694311111481 | K082113 | 000 |
| 15694311111467 | K082113 | 000 |