The following data is part of a premarket notification filed by Nox Medical Ehf with the FDA for Nox Rip Belts & Cables.
| Device ID | K151361 |
| 510k Number | K151361 |
| Device Name: | Nox RIP Belts & Cables |
| Classification | Ventilatory Effort Recorder |
| Applicant | NOX MEDICAL Ehf KATRINARTUNI 2 Reykjavik, IS 105 |
| Contact | Kolbrun E Ottosdottir |
| Correspondent | Kolbrun E Ottosdottir NOX MEDICAL Ehf KATRINARTUNI 2 Reykjavik, IS 105 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-21 |
| Decision Date | 2015-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15694311111382 | K151361 | 000 |
| 15694311110033 | K151361 | 000 |
| 15694311110156 | K151361 | 000 |
| 15694311110163 | K151361 | 000 |
| 15694311110170 | K151361 | 000 |
| 15694311110187 | K151361 | 000 |
| 15694311110194 | K151361 | 000 |
| 15694311110484 | K151361 | 000 |
| 15694311110491 | K151361 | 000 |
| 15694311110705 | K151361 | 000 |
| 15694311110958 | K151361 | 000 |
| 15694311110965 | K151361 | 000 |
| 15694311110972 | K151361 | 000 |
| 15694311111122 | K151361 | 000 |
| 15694311110026 | K151361 | 000 |