HEMASITE ACCESS MONITOR (TENT.) #RS-8200

Accessories, Blood Circuit, Hemodialysis

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Hemasite Access Monitor (tent.) #rs-8200.

Pre-market Notification Details

Device IDK811977
510k NumberK811977
Device Name:HEMASITE ACCESS MONITOR (TENT.) #RS-8200
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant RENAL SYSTEMS, 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 Received1981-07-13
Decision Date1981-07-31

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