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by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
1
Product Code
BXM
Stimulator, Nerve, Ac-Powered
2
Product Code
BXN
Stimulator, Nerve, Battery-Powered
2
Product Code
K
21
3049
STIMPOD NMS450 Nerve Stimulator
2
Cleared 510(K)
K
16
2086
MultiStim ECO
2
Cleared 510(K)
K
15
3045
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
2
Cleared 510(K)
K
14
3095
MiniStim MS-IVB Peripheral Nerve Stimulator
2
Cleared 510(K)
K
14
0853
STIMPOD ST2-3010 NERVE STIMULATOR
2
Cleared 510(K)
K
12
1743
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
2
Cleared 510(K)
K
11
1985
MYOGUIDE SYSTEM MODEL 8008
2
Cleared 510(K)
K
11
0118
STIMTRODE SINGLE USE NERVE STIMULATOR
2
Cleared 510(K)
K
10
2084
STIMPOD NMS450 NERVE STIMULATOR
2
Cleared 510(K)
K
09
3591
STIMPOD MODEL NMS-400 NERVE STIMULATOR
2
Cleared 510(K)
K
09
1155
ASCEND
2
Cleared 510(K)
K
07
2092
XPOD/XMAP NERVE STIMULATOR
2
Cleared 510(K)
K
07
0134
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
2
Cleared 510(K)
K
06
2478
CLAVIS
2
Cleared 510(K)
K
06
1983
STIMUPLEX PEN
2
Cleared 510(K)
K
06
1172
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
2
Cleared 510(K)
K
05
2313
STIMUPLEX HNS-12, MODEL 4892098
2
Cleared 510(K)
K
02
1033
STIMUPLEX-DIG-RC NERVE STIMULATOR
2
Cleared 510(K)
K
01
1308
MULTISTIM
2
Cleared 510(K)
K
99
0323
TE ME NA POLYSTIM NERVE STIMILATOR
2
Cleared 510(K)
K
00
3983
STIMUPLEX HNS-11
2
Cleared 510(K)
K
95
4525
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
2
Cleared 510(K)
K
91
4164
VITALMAX 840 SERIES
2
Cleared 510(K)
K
91
3184
MS-III MINISTIM
2
Cleared 510(K)
K
90
5092
NEUROMUSCULAR TRANSMISSION MONITOR
2
Cleared 510(K)
K
90
4025
MYOTRACK, MODEL HH 515
2
Cleared 510(K)
K
89
6368
MODIFIED AXOSTIM
2
Cleared 510(K)
K
89
2396
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
2
Cleared 510(K)
K
89
4786
BIO-INDUSTRY STIM POCHE(R)
2
Cleared 510(K)
K
89
3485
ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR
2
Cleared 510(K)
K
89
0746
MYOTEST DBS NERVE STIMULATOR
2
Cleared 510(K)
K
88
3807
AXOSTIM
2
Cleared 510(K)
K
88
3868
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
2
Cleared 510(K)
K
88
1842
TRACER
2
Cleared 510(K)
K
88
2438
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
2
Cleared 510(K)
K
87
0619
ACCELOGRAPH
2
Cleared 510(K)
K
87
0338
MODEL MS-II MINISTIM
2
Cleared 510(K)
K
86
4829
MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT
2
Cleared 510(K)
K
86
4830
TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK
2
Cleared 510(K)
K
86
2149
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
2
Cleared 510(K)
K
86
1935
MODEL 100 NERVE STIMULATOR
2
Cleared 510(K)
K
86
0187
MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING
2
Cleared 510(K)
K
86
0186
MYOTEST - NERVE STIMULATOR
2
Cleared 510(K)
K
86
0126
STIMUPLEX, NERVE STIMULATOR
2
Cleared 510(K)
K
85
3422
THE GRIPPER
2
Cleared 510(K)
K
85
3477
NERVE FINDER
2
Cleared 510(K)
K
85
3476
T4 MONITOR STIMULATOR COMPUTER
2
Cleared 510(K)
K
85
3849
MEDAR APM FORCE TRANSDUCER
2
Cleared 510(K)
K
85
2962
PERIPHERAL NERVE STIMULATOR MODEL A400
2
Cleared 510(K)
K
84
3175
NERVE STIMULATOR Q10
2
Cleared 510(K)
K
83
0058
MYOGRAPH 2000
2
Cleared 510(K)
K
82
3583
MYOTEST NERVE STIMULATOR
2
Cleared 510(K)
K
82
2139
STIMPEN
2
Cleared 510(K)
K
82
2157
PERIPHERAL NERVE STIMULATOR, MODEL A-200
2
Cleared 510(K)
K
82
2138
NEUROSTIM II
2
Cleared 510(K)
K
82
2137
DIGISTIM II
2
Cleared 510(K)
K
81
1614
NERVE STIMULATOR MODEL AA 1050
2
Cleared 510(K)
K
79
1442
BARD BIOMEDICAL NERVE LOCATOR
2
Cleared 510(K)
K
79
1047
NERVE STIMULATOR, DIGITAL PERIPHERAL
2
Cleared 510(K)
K
79
0123
STIMULATOR, BATTERY POWERED
2
Cleared 510(K)
K
77
1765
MYO-CHECK
2
Cleared 510(K)
K
77
1237
NERVE STIMULATORS
2
Cleared 510(K)
K
76
0614
PERIPHERAL NERVE STIMULATOR
2
Cleared 510(K)
BXO
Transducer, Gas Pressure
1
Product Code
BXP
Transducer, Gas Flow
1
Product Code
BXX
Calibrator, Pressure, Gas
1
Product Code
BXY
Flowmeter, Calibration, Gas
1
Product Code
BYM
Tube, Thorpe, Uncompensated
1
Product Code
BYR
Transducer, Gas Pressure, Differential
1
Product Code
BZQ
Monitor, Breathing Frequency
2
Product Code
CAN
Regulator, Pressure, Gas Cylinder
1
Product Code
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
2
Product Code
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
1
Product Code
CBA
Monitor, Air Embolism, Ultrasonic
2
Product Code
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
1
Product Code
ECX
Cylinder, Compressed Gas, And Valve
1
Product Code
FLS
Monitor, Apnea, Facility Use
2
Product Code
JAX
Pneumotachometer
2
Product Code
JEZ
Monitor, Lung Water Measurement
3
Product Code
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
2
Product Code
KOI
Stimulator, Nerve, Peripheral, Electric
2
Product Code
LKD
Monitor, Carbon-Dioxide, Cutaneous
2
Product Code
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
2
Product Code
MNR
Ventilatory Effort Recorder
2
Product Code
MRP
Analyzer, Nitric Oxide
2
Product Code
MRQ
Analyzer, Nitrogen Dioxide
2
Product Code
NPF
Monitor, Apnea, Home Use
2
Product Code
PRK
Device Indicating An Exhalation Event
2
Product Code
PUG
Analyzer, Nitrogen Dioxide, Exempt
2
Product Code
PXE
Pressure Monitoring (Air/Gas) Kit
1
Product Code
Subpart D—Prosthetic 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
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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 16 August 2024 at 11:05 pm
AN
/
subpart-c—monitoring-devices
/
BXN
/
K011308
View Source
MULTISTIM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011308
510(k) Type
Traditional
Applicant
PAJUNK GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2001
Days to Decision
213 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
BXM
Stimulator, Nerve, Ac-Powered
BXN
Stimulator, Nerve, Battery-Powered
K
21
3049
STIMPOD NMS450 Nerve Stimulator
K
16
2086
MultiStim ECO
K
15
3045
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K
14
3095
MiniStim MS-IVB Peripheral Nerve Stimulator
K
14
0853
STIMPOD ST2-3010 NERVE STIMULATOR
K
12
1743
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K
11
1985
MYOGUIDE SYSTEM MODEL 8008
K
11
0118
STIMTRODE SINGLE USE NERVE STIMULATOR
K
10
2084
STIMPOD NMS450 NERVE STIMULATOR
K
09
3591
STIMPOD MODEL NMS-400 NERVE STIMULATOR
K
09
1155
ASCEND
K
07
2092
XPOD/XMAP NERVE STIMULATOR
K
07
0134
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
K
06
2478
CLAVIS
K
06
1983
STIMUPLEX PEN
K
06
1172
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
K
05
2313
STIMUPLEX HNS-12, MODEL 4892098
K
02
1033
STIMUPLEX-DIG-RC NERVE STIMULATOR
K
01
1308
MULTISTIM
K
99
0323
TE ME NA POLYSTIM NERVE STIMILATOR
K
00
3983
STIMUPLEX HNS-11
K
95
4525
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K
91
4164
VITALMAX 840 SERIES
K
91
3184
MS-III MINISTIM
K
90
5092
NEUROMUSCULAR TRANSMISSION MONITOR
K
90
4025
MYOTRACK, MODEL HH 515
K
89
6368
MODIFIED AXOSTIM
K
89
2396
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
K
89
4786
BIO-INDUSTRY STIM POCHE(R)
K
89
3485
ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR
K
89
0746
MYOTEST DBS NERVE STIMULATOR
K
88
3807
AXOSTIM
K
88
3868
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
K
88
1842
TRACER
K
88
2438
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
K
87
0619
ACCELOGRAPH
K
87
0338
MODEL MS-II MINISTIM
K
86
4829
MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT
K
86
4830
TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK
K
86
2149
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K
86
1935
MODEL 100 NERVE STIMULATOR
K
86
0187
MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING
K
86
0186
MYOTEST - NERVE STIMULATOR
K
86
0126
STIMUPLEX, NERVE STIMULATOR
K
85
3422
THE GRIPPER
K
85
3477
NERVE FINDER
K
85
3476
T4 MONITOR STIMULATOR COMPUTER
K
85
3849
MEDAR APM FORCE TRANSDUCER
K
85
2962
PERIPHERAL NERVE STIMULATOR MODEL A400
K
84
3175
NERVE STIMULATOR Q10
K
83
0058
MYOGRAPH 2000
K
82
3583
MYOTEST NERVE STIMULATOR
K
82
2139
STIMPEN
K
82
2157
PERIPHERAL NERVE STIMULATOR, MODEL A-200
K
82
2138
NEUROSTIM II
K
82
2137
DIGISTIM II
K
81
1614
NERVE STIMULATOR MODEL AA 1050
K
79
1442
BARD BIOMEDICAL NERVE LOCATOR
K
79
1047
NERVE STIMULATOR, DIGITAL PERIPHERAL
K
79
0123
STIMULATOR, BATTERY POWERED
K
77
1765
MYO-CHECK
K
77
1237
NERVE STIMULATORS
K
76
0614
PERIPHERAL NERVE STIMULATOR
BXO
Transducer, Gas Pressure
BXP
Transducer, Gas Flow
BXX
Calibrator, Pressure, Gas
BXY
Flowmeter, Calibration, Gas
BYM
Tube, Thorpe, Uncompensated
BYR
Transducer, Gas Pressure, Differential
BZQ
Monitor, Breathing Frequency
CAN
Regulator, Pressure, Gas Cylinder
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
CBA
Monitor, Air Embolism, Ultrasonic
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
ECX
Cylinder, Compressed Gas, And Valve
FLS
Monitor, Apnea, Facility Use
JAX
Pneumotachometer
JEZ
Monitor, Lung Water Measurement
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
KOI
Stimulator, Nerve, Peripheral, Electric
LKD
Monitor, Carbon-Dioxide, Cutaneous
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
MNR
Ventilatory Effort Recorder
MRP
Analyzer, Nitric Oxide
MRQ
Analyzer, Nitrogen Dioxide
NPF
Monitor, Apnea, Home Use
PRK
Device Indicating An Exhalation Event
PUG
Analyzer, Nitrogen Dioxide, Exempt
PXE
Pressure Monitoring (Air/Gas) Kit
Subpart D—Prosthetic 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
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
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
AN
/
subpart-c—monitoring-devices
/
BXN
/
K011308
View Source
MULTISTIM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011308
510(k) Type
Traditional
Applicant
PAJUNK GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2001
Days to Decision
213 days
Submission Type
Summary