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by
Innolitics
Anesthesiology
Review Panel
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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
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
K
22
0530
Tetragraph Neuromuscular Transmission Monitor
2
Cleared 510(K)
K
22
0976
Life Scope PT BSM-1700 Series Bedside Monitor
2
Cleared 510(K)
K
21
2434
Neuromuscular Transmission Monitor TOF3D
2
Cleared 510(K)
K
21
3316
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
2
Cleared 510(K)
K
20
1949
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
2
Cleared 510(K)
K
19
2958
TwitchView System
2
Cleared 510(K)
K
19
0795
Tetragraph Neuromuscular Transmission Monitor
2
Cleared 510(K)
K
17
2690
ToFscan
2
Cleared 510(K)
K
17
2843
TwitchView System
2
Cleared 510(K)
K
16
2048
EZstim*III Peripheral Nerve Stimulator/Nerve Locator
2
Cleared 510(K)
K
05
1635
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
2
Cleared 510(K)
K
04
2003
INFINITY TRIDENT NMT POD
2
Cleared 510(K)
K
02
3342
NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
2
Cleared 510(K)
K
00
2889
PNS MAGNETIC STIMULATOR SYSTEM
2
Cleared 510(K)
K
99
2596
TOF-WATCH S
2
Cleared 510(K)
K
99
2598
TOF-WATCH SX
2
Cleared 510(K)
K
97
2698
TOF-WATCH
2
Cleared 510(K)
K
95
5026
AS/3 NMT MODULE
2
Cleared 510(K)
K
95
5031
MAXISTIM
2
Cleared 510(K)
K
95
4505
EZ STIM
2
Cleared 510(K)
K
95
3205
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
2
Cleared 510(K)
K
92
5159
TOF-GUARD TRANSMISSION MONITOR
2
Cleared 510(K)
K
92
4234
CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
2
Cleared 510(K)
K
86
1091
EASISTIM
2
Cleared 510(K)
K
84
0108
NEUROMUSCULAR TRANSMISSION MONITOR
2
Cleared 510(K)
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
/
KOI
/
K992598
View Source
TOF-WATCH SX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992598
510(k) Type
Special
Applicant
ORGANON TEKNIKA CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/30/1999
Days to Decision
27 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
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
K
22
0530
Tetragraph Neuromuscular Transmission Monitor
K
22
0976
Life Scope PT BSM-1700 Series Bedside Monitor
K
21
2434
Neuromuscular Transmission Monitor TOF3D
K
21
3316
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
K
20
1949
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
K
19
2958
TwitchView System
K
19
0795
Tetragraph Neuromuscular Transmission Monitor
K
17
2690
ToFscan
K
17
2843
TwitchView System
K
16
2048
EZstim*III Peripheral Nerve Stimulator/Nerve Locator
K
05
1635
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
K
04
2003
INFINITY TRIDENT NMT POD
K
02
3342
NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
K
00
2889
PNS MAGNETIC STIMULATOR SYSTEM
K
99
2596
TOF-WATCH S
K
99
2598
TOF-WATCH SX
K
97
2698
TOF-WATCH
K
95
5026
AS/3 NMT MODULE
K
95
5031
MAXISTIM
K
95
4505
EZ STIM
K
95
3205
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
K
92
5159
TOF-GUARD TRANSMISSION MONITOR
K
92
4234
CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
K
86
1091
EASISTIM
K
84
0108
NEUROMUSCULAR TRANSMISSION MONITOR
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
/
KOI
/
K992598
View Source
TOF-WATCH SX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992598
510(k) Type
Special
Applicant
ORGANON TEKNIKA CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/30/1999
Days to Decision
27 days
Submission Type
Summary