| Device Type ID | 151 |
| Device Name | Apparatus, Nitric Oxide Delivery |
| Regulation Description | Nitric Oxide Administration Apparatus. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5165 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MRN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 151 |
| Device | Apparatus, Nitric Oxide Delivery |
| Product Code | MRN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nitric Oxide Administration Apparatus. |
| CFR Regulation Number | 868.5165 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INO THERAPEUTICS/IKARIA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | INO Therapeutics (dba Ikaria) | II | Jan-23-2017 |
| 2 | INO Therapeutics (dba Ikaria) | II | Feb-27-2015 |
| 3 | INO Therapeutics (dba Ikaria) | II | Dec-12-2014 |
| 4 | INO Therapeutics (dba Ikaria) | II | May-02-2014 |
| 5 | INO Therapeutics LLC/dba Ikaria | II | Aug-08-2018 |