EXTRASENSR ULTRAFILTRATION MONITOR

Accessories, Blood Circuit, Hemodialysis

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extrasensr Ultrafiltration Monitor.

Pre-market Notification Details

Device IDK831433
510k NumberK831433
Device Name:EXTRASENSR ULTRAFILTRATION MONITOR
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, 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 Received1983-05-04
Decision Date1983-06-02

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