510(k) K823827

AMP 80/2 OUTFLOW MONITOR MODIFICATION by American Medical Products, Inc. — Product Code FKX

K823827 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "AMP 80/2 OUTFLOW MONITOR MODIFICATION". The FDA issued a decision of Substantially Equivalent on Mar 17, 1983. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. American Medical Products, Inc. has 29 other 510(k) clearances on record.