510(k) K041082

NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER by Newport Medical Instruments, Inc. — Product Code CAF

K041082 is an FDA 510(k) premarket notification submitted by Newport Medical Instruments, Inc. for the device "NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER". The FDA issued a decision of Substantially Equivalent on September 7, 2004. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Newport Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.