Apparatus, Nitric Oxide Delivery

Device Code: 151

Product Code(s): MRN

Device Classification Information

Device Type ID151
Device NameApparatus, Nitric Oxide Delivery
Regulation DescriptionNitric Oxide Administration Apparatus.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.5165 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMRN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID151
DeviceApparatus, Nitric Oxide Delivery
Product CodeMRN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionNitric Oxide Administration Apparatus.
CFR Regulation Number868.5165 [🔎]
Premarket Reviews
ManufacturerDecision
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
TPLC Last Update: 2019-04-02 19:29:47

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