FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
ETK
Tube, Toynbee Diagnostic
1
Product Code
ETM
Gustometer, Sterile
1
Product Code
ETN
Stimulator, Nerve
2
Product Code
K
24
1917
EARP Nerve Cuff Electrode
2
Cleared 510(K)
K
23
2888
Disposable Laryngeal Electrodes
2
Cleared 510(K)
K
23
0320
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
2
Cleared 510(K)
K
23
0853
EARP Nerve Cuff Electrode
2
Cleared 510(K)
K
23
1580
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
2
Cleared 510(K)
K
22
3254
C2 Xplore
2
Cleared 510(K)
K
21
2164
Mapping Suction Probe
2
Cleared 510(K)
K
21
3246
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
2
Cleared 510(K)
K
21
2355
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
2
Cleared 510(K)
K
20
0886
StimSite
2
Cleared 510(K)
K
15
2769
FREMAP ELECTRODE
2
Cleared 510(K)
K
15
2505
C2 NerveMonitor System
2
Cleared 510(K)
K
15
0005
Checkpoint, Checkpoint Head & Neck
2
Cleared 510(K)
K
13
3348
STIM PROBE
2
Cleared 510(K)
K
14
0400
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
2
Cleared 510(K)
K
12
2040
INVOTEC LARYNGEAL ELECTRODE
2
Cleared 510(K)
K
12
1931
NONDISPOSABLE STIMULATING INSTRUMENTS
2
Cleared 510(K)
K
12
1257
LARYNGEAL ELECTRODE
2
Cleared 510(K)
K
11
2686
NEXT GEN EMG ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
11
2717
NUVASIVE NVJJB SYSTEM
2
Cleared 510(K)
K
11
2426
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
2
Cleared 510(K)
K
11
2718
NUVASIVE NVM5 SYSTEM
2
Cleared 510(K)
K
11
2709
STIMULATION/DISSECTION INSTRUMENTS
2
Cleared 510(K)
K
11
1671
SEASPINE MONOPOLAR PROBE SYSYEM
2
Cleared 510(K)
K
11
0989
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
2
Cleared 510(K)
K
11
1597
DISPOSABLE STIMULATING ELECTRODE
2
Cleared 510(K)
K
11
2435
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
2
Cleared 510(K)
K
11
0696
NEURO CHECK DEVICE WITH IO-FLEX WIRE
2
Cleared 510(K)
K
11
0712
DRYTOUCH SUCTION STIMULATOR PROBE
2
Cleared 510(K)
K
11
0422
SURGICAL STIMULATORS
2
Cleared 510(K)
K
11
0138
PAIRED HYDROGEL ELECTRODE
2
Cleared 510(K)
K
10
3128
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
2
Cleared 510(K)
K
10
2862
NEUROVISION SE (NERVEANA)
2
Cleared 510(K)
K
10
0992
NEURALMAS
2
Cleared 510(K)
K
09
3373
LARYNGEAL SURFACE ELECTRODE
2
Cleared 510(K)
K
09
1874
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
2
Cleared 510(K)
K
09
2292
CHECKPOINT
2
Cleared 510(K)
K
09
2729
BAXANO NEURO CHECK DEVICE
2
Cleared 510(K)
K
08
3242
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
2
Cleared 510(K)
K
09
0838
STIMULUS/DISSECTION INSTRUMENTS
2
Cleared 510(K)
K
08
1742
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
2
Cleared 510(K)
K
07
2736
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
2
Cleared 510(K)
K
07
1349
NEUROSIGN LARYNGEAL ELECTRODES
2
Cleared 510(K)
K
06
3560
HILGER DUAL-STIM NERVE STIMULATOR
2
Cleared 510(K)
K
06
3305
STIMULATING BUR GUARD
2
Cleared 510(K)
K
06
2549
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
2
Cleared 510(K)
K
06
1365
CHECKPOINT WITH ACCUSTIM TECHNOLOGY
2
Cleared 510(K)
K
05
3141
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
2
Cleared 510(K)
K
05
1718
NUVASIVE NEUROVISION JJB SYSTEM
2
Cleared 510(K)
K
05
0162
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
2
Cleared 510(K)
K
04
0543
NUVASIVE NEUROVISION JJB SYSTEM
2
Cleared 510(K)
K
03
2083
NUVASIVE NEUROVISION JJB SYSTEM
2
Cleared 510(K)
K
03
1510
NIM-SPINE
2
Cleared 510(K)
K
03
1003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
2
Cleared 510(K)
K
02
1595
GYRUS ENT NERVE STIMULATOR
2
Cleared 510(K)
K
02
0955
NICOLET ELECTROCAUTERY DETECTOR
2
Cleared 510(K)
K
01
4165
STIMULUS - DISSECTION INSTRUMENTS
2
Cleared 510(K)
K
01
0213
MODIFICATION TO CAVERMAP SURGICAL AID
2
Cleared 510(K)
K
00
3745
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
2
Cleared 510(K)
K
00
0507
CAVERMAP SURGICAL AID
2
Cleared 510(K)
K
99
2869
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
2
Cleared 510(K)
K
99
1583
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
2
Cleared 510(K)
K
98
2595
NIM4
2
Cleared 510(K)
K
98
0148
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
2
Cleared 510(K)
K
97
0971
URO MED NERVE STIMULATOR
2
Cleared 510(K)
K
97
1143
NEURO PULSE II,III
2
Cleared 510(K)
K
96
4869
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
2
Cleared 510(K)
K
95
4601
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
2
Cleared 510(K)
K
94
5799
NEUROSIGN 100 IMPEDANCE METER
2
Cleared 510(K)
K
95
1641
NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
2
Cleared 510(K)
K
94
5242
NERVE MONITOR ELECTRODES/STIMULATOR PROBES
2
Cleared 510(K)
K
93
4733
STIMULATING SURGICAL INSTRUMENTS
2
Cleared 510(K)
K
93
4426
NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
2
Cleared 510(K)
K
93
3491
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
2
Cleared 510(K)
K
92
5640
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
2
Cleared 510(K)
K
92
5008
RLN NERVE LOCATOR/MONITOR; MODEL A
2
Cleared 510(K)
K
92
3056
NEUROSIGN MODEL 100
2
Cleared 510(K)
K
91
2508
NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION
2
Cleared 510(K)
K
90
5035
AXOSTIM NERVE STIMULATOR, MODIFICATION
2
Cleared 510(K)
K
90
5045
NERVE LOCATOR/STIMULATOR
2
Cleared 510(K)
K
89
5838
BRACKMANN EMG MONITORING SYSTEM
2
Cleared 510(K)
K
89
4930
DENTEC 4000
2
Cleared 510(K)
K
89
5676
HEMOSTAT/STIMULATOR PROBE
2
Cleared 510(K)
K
88
1757
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
2
Cleared 510(K)
K
87
4018
NEUROPROBE
2
Cleared 510(K)
K
88
0720
MONTGOMERY NERVE STIMULATOR
2
Cleared 510(K)
K
87
3964
NICOLET DISPOSABLE PRASS PROBE
2
Cleared 510(K)
K
87
2791
POREX NERVE LOCATOR
2
Cleared 510(K)
K
87
0272
MODEL 6110C OTOPHOR
2
Cleared 510(K)
K
84
3226
EVOKED RESPONSE ELECTRICAL STIMULATOR
2
Cleared 510(K)
K
83
3646
PULSATRON NERVE LOCATOR/STIMULATOR
2
Cleared 510(K)
K
83
1715
NEUROTRAC
2
Cleared 510(K)
K
78
1569
NERVE LOCATER/STIMULATOR
2
Cleared 510(K)
ETP
Stimulator, Caloric-Water
1
Product Code
ETR
Adaptor, Short Increment Sensitivity Index (Sisi)
1
Product Code
ETS
Generator, Electronic Noise (For Audiometric Testing)
2
Product Code
ETT
Cushion, Earphone (For Audiometric Testing)
1
Product Code
ETY
Tester, Auditory Impedance
2
Product Code
EWA
Set, Audiometer Calibration
1
Product Code
EWC
Chamber, Acoustic (For Audiometric Testing)
1
Product Code
EWO
Audiometer
2
Product Code
KHH
Stimulator, Caloric-Air
1
Product Code
KLX
Electroglottograph
2
Product Code
LYN
Apparatus, Visual Reinforcement Audiometric
2
Product Code
NAS
Tympanometer
2
Product Code
NNJ
Gustometer, Non-Sterile
1
Product Code
NRK
Kit, Test, Olfactory
2
Product Code
PTO
Tester, Auditory Impedance, Exempt
2
Product Code
PTP
Tympanometer, Exempt
2
Product Code
LWI
Ultrasound, Sinus
2
Product Code
PSV
Ultrasound Bronchoscope
2
Product Code
QJG
Device System, Imaging, Tympanic Membrane And Middle Ear
2
Product Code
QQE
Image Management Software For Planning Of Otologic And Neurotologic Procedures
2
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
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 30 November 2024 at 11:09 am
EN
/
subpart-b—diagnostic-devices
/
ETN
/
K971143
View Source
NEURO PULSE II,III
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971143
510(k) Type
Traditional
Applicant
AARON MEDICAL INDUSTRIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/6/1997
Days to Decision
70 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
ETK
Tube, Toynbee Diagnostic
ETM
Gustometer, Sterile
ETN
Stimulator, Nerve
K
24
1917
EARP Nerve Cuff Electrode
K
23
2888
Disposable Laryngeal Electrodes
K
23
0320
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
K
23
0853
EARP Nerve Cuff Electrode
K
23
1580
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K
22
3254
C2 Xplore
K
21
2164
Mapping Suction Probe
K
21
3246
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
K
21
2355
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
K
20
0886
StimSite
K
15
2769
FREMAP ELECTRODE
K
15
2505
C2 NerveMonitor System
K
15
0005
Checkpoint, Checkpoint Head & Neck
K
13
3348
STIM PROBE
K
14
0400
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
K
12
2040
INVOTEC LARYNGEAL ELECTRODE
K
12
1931
NONDISPOSABLE STIMULATING INSTRUMENTS
K
12
1257
LARYNGEAL ELECTRODE
K
11
2686
NEXT GEN EMG ENDOTRACHEAL TUBE
K
11
2717
NUVASIVE NVJJB SYSTEM
K
11
2426
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
K
11
2718
NUVASIVE NVM5 SYSTEM
K
11
2709
STIMULATION/DISSECTION INSTRUMENTS
K
11
1671
SEASPINE MONOPOLAR PROBE SYSYEM
K
11
0989
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K
11
1597
DISPOSABLE STIMULATING ELECTRODE
K
11
2435
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K
11
0696
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K
11
0712
DRYTOUCH SUCTION STIMULATOR PROBE
K
11
0422
SURGICAL STIMULATORS
K
11
0138
PAIRED HYDROGEL ELECTRODE
K
10
3128
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
K
10
2862
NEUROVISION SE (NERVEANA)
K
10
0992
NEURALMAS
K
09
3373
LARYNGEAL SURFACE ELECTRODE
K
09
1874
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
K
09
2292
CHECKPOINT
K
09
2729
BAXANO NEURO CHECK DEVICE
K
08
3242
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
K
09
0838
STIMULUS/DISSECTION INSTRUMENTS
K
08
1742
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
K
07
2736
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
K
07
1349
NEUROSIGN LARYNGEAL ELECTRODES
K
06
3560
HILGER DUAL-STIM NERVE STIMULATOR
K
06
3305
STIMULATING BUR GUARD
K
06
2549
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K
06
1365
CHECKPOINT WITH ACCUSTIM TECHNOLOGY
K
05
3141
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
K
05
1718
NUVASIVE NEUROVISION JJB SYSTEM
K
05
0162
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K
04
0543
NUVASIVE NEUROVISION JJB SYSTEM
K
03
2083
NUVASIVE NEUROVISION JJB SYSTEM
K
03
1510
NIM-SPINE
K
03
1003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K
02
1595
GYRUS ENT NERVE STIMULATOR
K
02
0955
NICOLET ELECTROCAUTERY DETECTOR
K
01
4165
STIMULUS - DISSECTION INSTRUMENTS
K
01
0213
MODIFICATION TO CAVERMAP SURGICAL AID
K
00
3745
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
K
00
0507
CAVERMAP SURGICAL AID
K
99
2869
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K
99
1583
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
K
98
2595
NIM4
K
98
0148
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K
97
0971
URO MED NERVE STIMULATOR
K
97
1143
NEURO PULSE II,III
K
96
4869
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K
95
4601
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
K
94
5799
NEUROSIGN 100 IMPEDANCE METER
K
95
1641
NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
K
94
5242
NERVE MONITOR ELECTRODES/STIMULATOR PROBES
K
93
4733
STIMULATING SURGICAL INSTRUMENTS
K
93
4426
NERVE INTEGRITY MONITOR-2 (NIM-2 XL)
K
93
3491
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
K
92
5640
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
K
92
5008
RLN NERVE LOCATOR/MONITOR; MODEL A
K
92
3056
NEUROSIGN MODEL 100
K
91
2508
NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION
K
90
5035
AXOSTIM NERVE STIMULATOR, MODIFICATION
K
90
5045
NERVE LOCATOR/STIMULATOR
K
89
5838
BRACKMANN EMG MONITORING SYSTEM
K
89
4930
DENTEC 4000
K
89
5676
HEMOSTAT/STIMULATOR PROBE
K
88
1757
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K
87
4018
NEUROPROBE
K
88
0720
MONTGOMERY NERVE STIMULATOR
K
87
3964
NICOLET DISPOSABLE PRASS PROBE
K
87
2791
POREX NERVE LOCATOR
K
87
0272
MODEL 6110C OTOPHOR
K
84
3226
EVOKED RESPONSE ELECTRICAL STIMULATOR
K
83
3646
PULSATRON NERVE LOCATOR/STIMULATOR
K
83
1715
NEUROTRAC
K
78
1569
NERVE LOCATER/STIMULATOR
ETP
Stimulator, Caloric-Water
ETR
Adaptor, Short Increment Sensitivity Index (Sisi)
ETS
Generator, Electronic Noise (For Audiometric Testing)
ETT
Cushion, Earphone (For Audiometric Testing)
ETY
Tester, Auditory Impedance
EWA
Set, Audiometer Calibration
EWC
Chamber, Acoustic (For Audiometric Testing)
EWO
Audiometer
KHH
Stimulator, Caloric-Air
KLX
Electroglottograph
LYN
Apparatus, Visual Reinforcement Audiometric
NAS
Tympanometer
NNJ
Gustometer, Non-Sterile
NRK
Kit, Test, Olfactory
PTO
Tester, Auditory Impedance, Exempt
PTP
Tympanometer, Exempt
LWI
Ultrasound, Sinus
PSV
Ultrasound Bronchoscope
QJG
Device System, Imaging, Tympanic Membrane And Middle Ear
QQE
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
subpart-b—diagnostic-devices
/
ETN
/
K971143
View Source
NEURO PULSE II,III
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971143
510(k) Type
Traditional
Applicant
AARON MEDICAL INDUSTRIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/6/1997
Days to Decision
70 days
Submission Type
Statement