PRISMAFLO II

Accessories, Blood Circuit, Hemodialysis

STIHLER ELECTRONIC GMBH

The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Prismaflo Ii.

Pre-market Notification Details

Device IDK082758
510k NumberK082758
Device Name:PRISMAFLO II
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach,  NY  11789 -1734
ContactStephen T Mlcoch
CorrespondentStephen T Mlcoch
STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach,  NY  11789 -1734
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-19
Decision Date2008-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260114149897 K082758 000

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