510(k) K053203

MYNEB NEBULIZER, MODEL RDD100 by Respironics New Jersey, Inc. — Product Code CAF

K053203 is an FDA 510(k) premarket notification submitted by Respironics New Jersey, Inc. for the device "MYNEB NEBULIZER, MODEL RDD100". The FDA issued a decision of Substantially Equivalent on December 20, 2005. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Respironics New Jersey, Inc. has at least 4 other 510(k) clearances on record.