RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT

System, Perfusion, Kidney

WATERS INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Rm3 Renal Preservation System--control Unit.

Pre-market Notification Details

Device IDK971571
510k NumberK971571
Device Name:RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
ClassificationSystem, Perfusion, Kidney
Applicant WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester,  MN  55903 -6117
ContactDave Schollman
CorrespondentDave Schollman
WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester,  MN  55903 -6117
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-30
Decision Date1997-07-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B154R3920140024C00 K971571 000
B154R39101410030 K971571 000
B154R39101410040 K971571 000
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B154R39101410100 K971571 000
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B154R39000560013 K971571 000
B154R00060040000 K971571 000
B154R00081290000 K971571 000
B154R00126910000 K971571 000
B154R00126910050 K971571 000
B154R00150930010 K971571 000
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B154R32000910050 K971571 000
B154R39000400040 K971571 000
B154R39101410110 K971571 000
B154R39101410120 K971571 000
B154R39101420080 K971571 000
B154R39101420090 K971571 000
B154R39101420100 K971571 000
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B154R39101420120 K971571 000
B154R39101420130 K971571 000
B154R39101420140 K971571 000
B154R39201400230 K971571 000
B154R39101420070 K971571 000
B154R39101420060 K971571 000
B154R39101410130 K971571 000
B154R39101410140 K971571 000
B154R39101410150 K971571 000
B154R39101410160 K971571 000
B154R39101420020 K971571 000
B154R39101420030 K971571 000
B154R39101420040 K971571 000
B154R39101420050 K971571 000
B15431800030050 K971571 000

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