MODEL DM-333 DIALYSIS CONTROL STATION

System, Dialysate Delivery, Central Multiple Patient

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Model Dm-333 Dialysis Control Station.

Pre-market Notification Details

Device IDK811444
510k NumberK811444
Device Name:MODEL DM-333 DIALYSIS CONTROL STATION
ClassificationSystem, Dialysate Delivery, Central Multiple Patient
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKQ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-22
Decision Date1981-06-23

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