510(k) K994352

SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 by Hudson Respiratory Care, Inc. — Product Code CAF

K994352 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896". The FDA issued a decision of Substantially Equivalent on March 22, 2000. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Hudson Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.