510(k) K960675

WALKHALER PORTABLE COMPRESSOR MODEL 45F70 by Pari Holding Co. — Product Code CAF

K960675 is an FDA 510(k) premarket notification submitted by Pari Holding Co. for the device "WALKHALER PORTABLE COMPRESSOR MODEL 45F70". The FDA issued a decision of Substantially Equivalent on May 17, 1996. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Pari Holding Co. has at least 7 other 510(k) clearances on record.