The following data is part of a premarket notification filed by Nox Medical with the FDA for Nox Sleep System.
| Device ID | K192469 |
| 510k Number | K192469 |
| Device Name: | Nox Sleep System |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | Nox Medical Katrinartuni 2 Reykjavik, IS 105 |
| Contact | Kolburn E Ottosdottir |
| Correspondent | John J Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-09 |
| Decision Date | 2019-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15694311111375 | K192469 | 000 |
| 15694311111610 | K192469 | 000 |
| 15694311111627 | K192469 | 000 |
| 15694311111566 | K192469 | 000 |
| 15694311111597 | K192469 | 000 |
| 15694311110682 | K192469 | 000 |
| 15694311110699 | K192469 | 000 |
| 15694311111498 | K192469 | 000 |
| 15694311111504 | K192469 | 000 |
| 15694311110019 | K192469 | 000 |
| 15694311110095 | K192469 | 000 |
| 15694311110453 | K192469 | 000 |
| 15694311110521 | K192469 | 000 |
| 15694311110590 | K192469 | 000 |
| 15694311110903 | K192469 | 000 |
| 15694311111146 | K192469 | 000 |
| 15694311111368 | K192469 | 000 |
| 15694311111665 | K192469 | 000 |