Atlas FDA

MRO

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Apparatus, Nitric Oxide, Backup Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5165
Medical specialty
Anesthesiology
Flags
Life-sustaining
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RecordFirmDate
INOBLENDER (K122689)Ino Therapeutics2012-11-07
INO THERAPEUTICS INOBLENDER, MODEL 10004 (K052663)Ino Therapeutics2005-11-04
FADASIS MEDICAL FM-1 NO BLENDER (K011874)Fadasis Medical, Inc.2001-07-20
FADASSI MEDICAL FM-1 NO BLENDER (K003665)Fadasis Medical, Inc.2001-02-23

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Every clearance here is in the API, with alerts when new ones post.