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 |