MRO · Class II · 21 CFR 868.5165

FDA Product Code MRO: Apparatus, Nitric Oxide, Backup Delivery

Leading manufacturers include Fadasis Medical, Inc. and Ino Therapeutics.

4
Total
4
Cleared
56d
Avg days
2001
Since

FDA 510(k) Cleared Apparatus, Nitric Oxide, Backup Delivery Devices (Product Code MRO)

4 devices
1–4 of 4
Cleared Nov 07, 2012
INOBLENDER
K122689
Ino Therapeutics
Anesthesiology · 64d
Cleared Nov 04, 2005
INO THERAPEUTICS INOBLENDER, MODEL 10004
K052663
Ino Therapeutics
Anesthesiology · 38d
Cleared Jul 20, 2001
FADASIS MEDICAL FM-1 NO BLENDER
K011874
Fadasis Medical, Inc.
Anesthesiology · 35d
Cleared Feb 23, 2001
FADASSI MEDICAL FM-1 NO BLENDER
K003665
Fadasis Medical, Inc.
Anesthesiology · 87d

About Product Code MRO - Regulatory Context