510(k) K000653

AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 by Pulmonox Medical Corp. — Product Code MRN

K000653 is an FDA 510(k) premarket notification submitted by Pulmonox Medical Corp. for the device "AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002". The FDA issued a decision of Substantially Equivalent on August 4, 2000. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Pulmonox Medical Corp. has at least 2 other 510(k) clearances on record.