510(k) K894138

MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD by Medipart Jerry Alexander — Product Code CAF

K894138 is an FDA 510(k) premarket notification submitted by Medipart Jerry Alexander for the device "MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD". The FDA issued a decision of Substantially Equivalent on September 26, 1989. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medipart Jerry Alexander has at least 10 other 510(k) clearances on record.