MRN · Class II · 21 CFR 868.5165

FDA Product Code MRN: Apparatus, Nitric Oxide Delivery

Leading manufacturers include Ino Therapeutics, Mallinckrodt Manufacturing, LLC and Ino Therapeutics, LLC.

33
Total
32
Cleared
169d
Avg days
2000
Since
33 devices
25–33 of 33
Cleared Aug 28, 2008
INOMAX DS (DELIVERY SYSTEM)
K081691
Ino Therapeutics, LLC
Anesthesiology · 72d
Cleared Aug 06, 2008
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K080484
Ino Therapeutics
Anesthesiology · 166d
Cleared Oct 03, 2007
INOMAX DS
K071516
Ino Therapeutics, LLC
Anesthesiology · 121d
Cleared Apr 27, 2007
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K070867
Ino Therapeutics, LLC
Anesthesiology · 29d
Cleared Dec 14, 2006
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K061901
Ino Therapeutics
Anesthesiology · 162d
Cleared Aug 04, 2000
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
K000653
Pulmonox Medical Corp.
Anesthesiology · 158d
Cleared Feb 10, 2000
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186
Datex-Ohmeda
Anesthesiology · 27d
Not Cleared Jan 11, 2000
OHMEDA INOVENT DELIVERY SYSTEM
DEN000001
Ohmeda Medical
Anesthesiology · 4d