AMP AUTOMATIC CYCLER STAND

System, Dialysate Delivery, Semi-automatic, Peritoneal

AMERICAN MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Amp Automatic Cycler Stand.

Pre-market Notification Details

Device IDK790091
510k NumberK790091
Device Name:AMP AUTOMATIC CYCLER STAND
ClassificationSystem, Dialysate Delivery, Semi-automatic, Peritoneal
Applicant AMERICAN MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKPF  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-16
Decision Date1979-02-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.