Apparatus, Nitric Oxide, Backup Delivery
The Nitric Oxide Backup Delivery Apparatus is an anesthesiology device that serves as a redundant or emergency backup system for delivering inhaled nitric oxide to mechanically ventilated patients, ensuring uninterrupted therapy if the primary delivery system fails. Classified as FDA Class 2 under 21 CFR 868.5165, it requires 510(k) premarket notification. The product code is MRO, and it carries a life-sustaining support flag.
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Basic Information
- Product Code
- MRO
- Device Class
- FDA class 2
- Regulation Number
- 868.5165
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122689 | INOBLENDER | Nov 07, 2012 | Substantially Equivalent | Ino Therapeutics |
| K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 | Nov 04, 2005 | Substantially Equivalent | Ino Therapeutics |
| K011874 | FADASIS MEDICAL FM-1 NO BLENDER | Jul 20, 2001 | Substantially Equivalent | Fadasis Medical, Inc. |
| K003665 | FADASSI MEDICAL FM-1 NO BLENDER | Feb 23, 2001 | Substantially Equivalent | Fadasis Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.