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Review Panel
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
IKN
Electromyograph, Diagnostic
2
Product Code
K
17
2743
Natus VikingQuest
2
Cleared 510(K)
K
16
3150
ViMove2
2
Cleared 510(K)
K
16
2383
Cadwell Sierra Summit, Cadwell Sierra Ascent
2
Cleared 510(K)
K
14
2494
ViMove
2
Cleared 510(K)
K
13
1094
VIMOVE
2
Cleared 510(K)
K
12
3902
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
2
Cleared 510(K)
K
12
3399
MYOVISION 3.0 WIREFREE SYSTEM
2
Cleared 510(K)
K
11
3074
CMAP PRO
2
Cleared 510(K)
K
10
2610
FOCUS EMG DEVICE
2
Cleared 510(K)
K
11
0048
CERSR ELECTROMYOGRAPHY SYSTEM
2
Cleared 510(K)
K
08
3679
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
2
Cleared 510(K)
K
07
3415
NEMUS SYSTEM; NEMUS PC PERIPHERAL
2
Cleared 510(K)
K
06
3447
INSIGHT DISCOVERY
2
Cleared 510(K)
K
05
2112
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
2
Cleared 510(K)
K
03
1995
COMPREHENSIVE NEUROMUSCULAR PROFILER
2
Cleared 510(K)
K
03
3452
CWAS 1000
2
Cleared 510(K)
K
02
3209
INSIGHT MILLENNIUM III
2
Cleared 510(K)
K
02
4316
NIM-PRS
2
Cleared 510(K)
K
02
3147
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
2
Cleared 510(K)
K
02
2719
PHYSICAL MONITORING REGISTRATION UNIT
2
Cleared 510(K)
K
01
0590
NEUROPACK MICRO, MODEL MED-9100A SERIES
2
Cleared 510(K)
K
00
2104
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
2
Cleared 510(K)
K
00
1800
ACCUWARM EMG HEAT LAMP
2
Cleared 510(K)
K
00
1562
NEURO SCAN MEDICAL SYSTEMS A4000
2
Cleared 510(K)
K
00
0812
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
2
Cleared 510(K)
K
00
0220
MA-300 ELECTROMYOGRAPHY SYSTEM
2
Cleared 510(K)
K
99
3878
JE 2000
2
Cleared 510(K)
K
99
0766
CERSR ELECTROMYOGRAPHY SYSTEM
2
Cleared 510(K)
K
98
4052
SYNERGY IOM SYSTEM
2
Cleared 510(K)
K
97
2419
TOENNIES NEUROSCREEN SYSTEM
2
Cleared 510(K)
K
97
4385
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
2
Cleared 510(K)
K
97
4010
ADVANTAGE EMG SYSTEM, MODEL #A100
2
Cleared 510(K)
K
97
3355
ADVANTAGE 3000
2
Cleared 510(K)
K
94
1144
EXCEL EMG
2
Cleared 510(K)
K
94
2965
COMPUTER DYNO/GONIO/MYO GRAPHY
2
Cleared 510(K)
K
95
2655
B & L ELECTRODE
2
Cleared 510(K)
K
94
4787
INTEGRATED MOVEMENT ANALYZER
2
Cleared 510(K)
K
93
5368
STC DIAGNOSTIC 8000
2
Cleared 510(K)
K
93
0328
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
2
Cleared 510(K)
K
92
2488
PHASIS ELECTROMYOGRAPH
2
Cleared 510(K)
K
90
1732
EMG ACCESSORY FOR POSTUROGRAPHY
2
Cleared 510(K)
K
89
3130
EMG NAVIGATOR & EMG TRAVELER
2
Cleared 510(K)
K
88
3781
NICOLET NEUROPORT/ACE SYSTEM
2
Cleared 510(K)
K
89
0495
NICOLET VIKING II SYSTEM
2
Cleared 510(K)
K
88
0977
ADR-2000 AMBULATORY DATA RECORDING SYSTEM
2
Cleared 510(K)
K
88
0976
AL-200B MUSCLE ACTIVITY INTEGRATOR
2
Cleared 510(K)
K
88
0573
MODIFIED NICOLET VIKING SYSTEM
2
Cleared 510(K)
K
87
2836
SPINOSCOPE
2
Cleared 510(K)
K
86
4660
MODEL M402 EMG MONITOR
2
Cleared 510(K)
K
86
4408
EMG-1, MOTOR NERVE MONITOR
2
Cleared 510(K)
K
86
4641
VENTEX-IA
2
Cleared 510(K)
K
86
4630
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
2
Cleared 510(K)
K
86
2236
MYOLAB II, MODEL ML-200
2
Cleared 510(K)
K
85
3804
VICON (MODIFICATION)
2
Cleared 510(K)
K
84
2649
BATH TUB TRANSFER CHAIR
2
Cleared 510(K)
K
84
2956
NICOLET VIKING
2
Cleared 510(K)
K
84
2612
COMPACT AUDITORY
2
Cleared 510(K)
K
84
2611
CA2000
2
Cleared 510(K)
K
84
2613
COMPACT VISUAL
2
Cleared 510(K)
K
83
3927
ELECTRO-MYOSCOPE 85
2
Cleared 510(K)
K
83
0702
NICOLET EMG SATELLITE
2
Cleared 510(K)
K
82
3562
EMG MODULES FOR POLYGRAPH SYSTEM
2
Cleared 510(K)
K
82
2624
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
2
Cleared 510(K)
K
82
1910
ANESTHESIA & BRAIN MONITOR
2
Cleared 510(K)
K
82
1237
NEUROMATIC 2000
2
Cleared 510(K)
K
81
2715
TECA #TE 8
2
Cleared 510(K)
K
80
2637
TECA MODEL-10 ELECTROMYOGRAPH
2
Cleared 510(K)
K
80
0648
CADWELL 7200
2
Cleared 510(K)
K
79
1235
CADWELL 7000 ELECTROMYOGRAPH MACHINE
2
Cleared 510(K)
K
79
0664
MODEL 1309 AUDIO MONITOR
2
Cleared 510(K)
K
78
1399
TECA MODEL B9 ELECTROMYOGRAPH
2
Cleared 510(K)
K
78
0541
PRESSURE MODULES MODELS 1855 & 1856
2
Cleared 510(K)
K
77
2005
MYOTONE EMG MONITOR
2
Cleared 510(K)
IKT
Electrode, Needle, Diagnostic Electromyograph
2
Product Code
LYH
Arthrometer
1
Product Code
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
NE
/
subpart-b—physical-medicine-diagnostic-devices
/
IKN
/
K002104
View Source
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002104
510(k) Type
Traditional
Applicant
MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/10/2000
Days to Decision
90 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
IKN
Electromyograph, Diagnostic
K
17
2743
Natus VikingQuest
K
16
3150
ViMove2
K
16
2383
Cadwell Sierra Summit, Cadwell Sierra Ascent
K
14
2494
ViMove
K
13
1094
VIMOVE
K
12
3902
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
K
12
3399
MYOVISION 3.0 WIREFREE SYSTEM
K
11
3074
CMAP PRO
K
10
2610
FOCUS EMG DEVICE
K
11
0048
CERSR ELECTROMYOGRAPHY SYSTEM
K
08
3679
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
K
07
3415
NEMUS SYSTEM; NEMUS PC PERIPHERAL
K
06
3447
INSIGHT DISCOVERY
K
05
2112
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
K
03
1995
COMPREHENSIVE NEUROMUSCULAR PROFILER
K
03
3452
CWAS 1000
K
02
3209
INSIGHT MILLENNIUM III
K
02
4316
NIM-PRS
K
02
3147
ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
K
02
2719
PHYSICAL MONITORING REGISTRATION UNIT
K
01
0590
NEUROPACK MICRO, MODEL MED-9100A SERIES
K
00
2104
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
K
00
1800
ACCUWARM EMG HEAT LAMP
K
00
1562
NEURO SCAN MEDICAL SYSTEMS A4000
K
00
0812
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
K
00
0220
MA-300 ELECTROMYOGRAPHY SYSTEM
K
99
3878
JE 2000
K
99
0766
CERSR ELECTROMYOGRAPHY SYSTEM
K
98
4052
SYNERGY IOM SYSTEM
K
97
2419
TOENNIES NEUROSCREEN SYSTEM
K
97
4385
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K
97
4010
ADVANTAGE EMG SYSTEM, MODEL #A100
K
97
3355
ADVANTAGE 3000
K
94
1144
EXCEL EMG
K
94
2965
COMPUTER DYNO/GONIO/MYO GRAPHY
K
95
2655
B & L ELECTRODE
K
94
4787
INTEGRATED MOVEMENT ANALYZER
K
93
5368
STC DIAGNOSTIC 8000
K
93
0328
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K
92
2488
PHASIS ELECTROMYOGRAPH
K
90
1732
EMG ACCESSORY FOR POSTUROGRAPHY
K
89
3130
EMG NAVIGATOR & EMG TRAVELER
K
88
3781
NICOLET NEUROPORT/ACE SYSTEM
K
89
0495
NICOLET VIKING II SYSTEM
K
88
0977
ADR-2000 AMBULATORY DATA RECORDING SYSTEM
K
88
0976
AL-200B MUSCLE ACTIVITY INTEGRATOR
K
88
0573
MODIFIED NICOLET VIKING SYSTEM
K
87
2836
SPINOSCOPE
K
86
4660
MODEL M402 EMG MONITOR
K
86
4408
EMG-1, MOTOR NERVE MONITOR
K
86
4641
VENTEX-IA
K
86
4630
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K
86
2236
MYOLAB II, MODEL ML-200
K
85
3804
VICON (MODIFICATION)
K
84
2649
BATH TUB TRANSFER CHAIR
K
84
2956
NICOLET VIKING
K
84
2612
COMPACT AUDITORY
K
84
2611
CA2000
K
84
2613
COMPACT VISUAL
K
83
3927
ELECTRO-MYOSCOPE 85
K
83
0702
NICOLET EMG SATELLITE
K
82
3562
EMG MODULES FOR POLYGRAPH SYSTEM
K
82
2624
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K
82
1910
ANESTHESIA & BRAIN MONITOR
K
82
1237
NEUROMATIC 2000
K
81
2715
TECA #TE 8
K
80
2637
TECA MODEL-10 ELECTROMYOGRAPH
K
80
0648
CADWELL 7200
K
79
1235
CADWELL 7000 ELECTROMYOGRAPH MACHINE
K
79
0664
MODEL 1309 AUDIO MONITOR
K
78
1399
TECA MODEL B9 ELECTROMYOGRAPH
K
78
0541
PRESSURE MODULES MODELS 1855 & 1856
K
77
2005
MYOTONE EMG MONITOR
IKT
Electrode, Needle, Diagnostic Electromyograph
LYH
Arthrometer
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—physical-medicine-diagnostic-devices
/
IKN
/
K002104
View Source
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002104
510(k) Type
Traditional
Applicant
MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/10/2000
Days to Decision
90 days
Submission Type
Summary