MINNILERT(R) PRESSURE MONITOR

Accessories, Blood Circuit, Hemodialysis

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Minnilert(r) Pressure Monitor.

Pre-market Notification Details

Device IDK913483
510k NumberK913483
Device Name:MINNILERT(R) PRESSURE MONITOR
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactLeroy J Fischbach
CorrespondentLeroy J Fischbach
MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-06
Decision Date1991-09-27

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