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510(k) K024316

Device
NIM-PRS
Applicant
MEDTRONIC XOMED, INC.
510(k) number
K024316
Product code
IKN  
Decision
Substantially Equivalent (SESE)
Decision date
2003-01-06
Date received
2002-12-26
Regulation
890.1375
Classification name
Electromyograph, Diagnostic
Medical specialty
Physical Medicine
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
MARTIN SARGENT
Address
6743 Southpoint Dr. N. Jacksonville FL US 32216 32216

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.2017-03-01
K142494ViMoveDorsavi, Ltd.2015-05-28
K131094VIMOVEDorsa VI Pty., Ltd.2014-07-11
K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLC2013-09-13
K123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.2013-08-01
K113074CMAP PROMedical Technologies, Inc.2012-02-02
K102610FOCUS EMG DEVICETeleemg, LLC USA2011-03-04
K110048CERSR ELECTROMYOGRAPHY SYSTEMSpinematrix, Inc.2011-01-26
K083679UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1Uroval2009-09-11
K073415NEMUS SYSTEM; NEMUS PC PERIPHERALEb Neuro S.P.A.2008-05-23
K063447INSIGHT DISCOVERYFasstech2007-08-16
K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059Excel Tech. , Ltd.2005-10-28
K031995COMPREHENSIVE NEUROMUSCULAR PROFILERMedical Technologies Unlimited, Inc.2004-01-07

Legacy Summary#

summary

FDA Review#

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