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510(k) K063447

Device
INSIGHT DISCOVERY
Applicant
FASSTECH
510(k) number
K063447
Product code
IKN  
Decision
Substantially Equivalent (SESE)
Decision date
2007-08-16
Date received
2006-11-15
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
LEE BRODY
Address
76 Treble Cove Rd. Bldg. #2 North Billerica MA US 01862 01862

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172743Natus VikingQuestNatus Neurology Incorporated2017-12-19
K163150ViMove2Dorsavi, Ltd.2017-07-14
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
K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059Excel Tech. , Ltd.2005-10-28
K031995COMPREHENSIVE NEUROMUSCULAR PROFILERMedical Technologies Unlimited, Inc.2004-01-07
K033452CWAS 1000Fasstech2003-11-28

Legacy Summary#

summary

FDA Review#

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