510(k) K052663

INO THERAPEUTICS INOBLENDER, MODEL 10004 by Ino Therapeutics — Product Code MRO

K052663 is an FDA 510(k) premarket notification submitted by Ino Therapeutics for the device "INO THERAPEUTICS INOBLENDER, MODEL 10004". The FDA issued a decision of Substantially Equivalent on November 4, 2005. The device falls under product code MRO (Apparatus, Nitric Oxide, Backup Delivery), a Class II device regulated under 21 CFR 868.5165. Ino Therapeutics has at least 10 other 510(k) clearances on record.