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MRO — Apparatus, Nitric Oxide, Backup Delivery Class II

FDA Device Classification

Classification Details

Product Code
MRO
Device Class
Class II
Regulation Number
868.5165
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K122689ino therapeuticsINOBLENDERNovember 7, 2012
K052663ino therapeuticsINO THERAPEUTICS INOBLENDER, MODEL 10004November 4, 2005
K011874fadasis medicalFADASIS MEDICAL FM-1 NO BLENDERJuly 20, 2001
K003665fadasis medicalFADASSI MEDICAL FM-1 NO BLENDERFebruary 23, 2001