ERIKA NEGATIVE PRESS. ARTERIAL BLOOD

Accessories, Blood Circuit, Hemodialysis

ERIKA, INC.

The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Negative Press. Arterial Blood.

Pre-market Notification Details

Device IDK842436
510k NumberK842436
Device Name:ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant ERIKA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-20
Decision Date1984-07-13

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