510(k) K042655

INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 by Respironics New Jersey, Inc. — Product Code CAF

K042655 is an FDA 510(k) premarket notification submitted by Respironics New Jersey, Inc. for the device "INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456". The FDA issued a decision of Substantially Equivalent on October 13, 2004. 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.