The following data is part of a premarket notification filed by Nox Medical with the FDA for Qdc-pro, And Nox-rip.
| Device ID | K124062 |
| 510k Number | K124062 |
| Device Name: | QDC-PRO, AND NOX-RIP |
| Classification | Ventilatory Effort Recorder |
| Applicant | NOX MEDICAL VATNAGORDUM 18 Reykjavik, IS 104 |
| Contact | Kolbrun E Ottosdottir |
| Correspondent | Kolbrun E Ottosdottir NOX MEDICAL VATNAGORDUM 18 Reykjavik, IS 104 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-31 |
| Decision Date | 2013-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15694311110866 | K124062 | 000 |
| 15694311110736 | K124062 | 000 |
| 15694311110514 | K124062 | 000 |
| 15694311110507 | K124062 | 000 |