CONDUCTIVITY STANDARD SOLUTION-METERCARE

Solution-test Standard-conductivity, Dialysis

IBP INSTRUMENTS GMBH

The following data is part of a premarket notification filed by Ibp Instruments Gmbh with the FDA for Conductivity Standard Solution-metercare.

Pre-market Notification Details

Device IDK032075
510k NumberK032075
Device Name:CONDUCTIVITY STANDARD SOLUTION-METERCARE
ClassificationSolution-test Standard-conductivity, Dialysis
Applicant IBP INSTRUMENTS GMBH SUTELSTRASSE 7A Hannover,  DE D30659
ContactWerner Pfingstmann
CorrespondentStefan Preiss
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeFKH  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-07-07
Decision Date2003-09-17
Summary:summary

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