510(k) K896375

PREEMICARE NEBUTECH NEBULIZER SYSTEM by Preemicare Corp. — Product Code CAF

K896375 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "PREEMICARE NEBUTECH NEBULIZER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Preemicare Corp. has at least 8 other 510(k) clearances on record.