510(k) K003665

FADASSI MEDICAL FM-1 NO BLENDER by Fadasis Medical, Inc. — Product Code MRO

K003665 is an FDA 510(k) premarket notification submitted by Fadasis Medical, Inc. for the device "FADASSI MEDICAL FM-1 NO BLENDER". The FDA issued a decision of Substantially Equivalent on February 23, 2001. The device falls under product code MRO (Apparatus, Nitric Oxide, Backup Delivery), a Class II device regulated under 21 CFR 868.5165. Fadasis Medical, Inc. has at least 1 other 510(k) clearance on record.