FDA Browser
by
Innolitics
Anesthesiology
Review Panel
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
Miscellaneous
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
HEQ
Monitor, Pressure, Arterial, Fetal, Ultrasonic
2
Product Code
HEI
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
2
Product Code
HEJ
Monitor, Hemic Sound, Ultrasonic
2
Product Code
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
2
Product Code
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
2
Product Code
HEM
Imager, Ultrasonic Obstetric-Gynecologic
2
Product Code
HEN
Caliper, Fetal Head, Ultrasonic
2
Product Code
HEO
Analyzer, Data, Obstetric
3
Product Code
HEP
Monitor, Blood-Flow, Ultrasonic
2
Product Code
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
2
Product Code
K
14
0163
KOALA TOCO
2
Cleared 510(K)
K
06
1044
FEATHERLITE AQUA TOCODYNAMOMETER
2
Cleared 510(K)
K
04
0392
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
2
Cleared 510(K)
K
01
3477
TOCO LITE, MODEL TD-01
2
Cleared 510(K)
K
99
4353
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
2
Cleared 510(K)
K
99
2811
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
2
Cleared 510(K)
K
95
4847
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
2
Cleared 510(K)
K
95
2579
TOCO TRANSDUCER
2
Cleared 510(K)
K
92
0152
BUBBLE TOCO
2
Cleared 510(K)
K
91
0282
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
2
Cleared 510(K)
P
89
0063
GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)
2
PMA Approval
P
89
0063
GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
2
PMA Approval
P
89
0063
GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
2
PMA Approval
K
90
4691
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST
2
Cleared 510(K)
K
90
3623
MODEL600 UTERINE ACTIVITY MONITOR
2
Cleared 510(K)
K
90
2104
ORION WATCHGUARD
2
Cleared 510(K)
P
89
0063
GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
2
PMA Approval
K
89
4030
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
2
Cleared 510(K)
K
89
3770
TERM GUARD II DEVICE
2
Cleared 510(K)
K
89
1997
CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER
2
Cleared 510(K)
K
88
2080
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
2
Cleared 510(K)
K
87
4631
HEALTHPHONE TOCO MODEL
2
Cleared 510(K)
K
87
3150
PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
2
Cleared 510(K)
K
86
0933
AIR-CUSHION TOCOTONOMETER
2
Cleared 510(K)
K
85
3856
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
2
Cleared 510(K)
K
84
3011
TERM GUARD 5000 UTERINE ACTIVITY
2
Cleared 510(K)
K
84
0747
TOCO DATA TELEPHONE TRANSMITTER DT100P
2
Cleared 510(K)
HFN
Transducer, Pressure, Intrauterine
2
Product Code
HFO
Recorder, Pressure, Intrauterine
2
Product Code
HFP
Monitor, Phonocardiographic, Fetal
2
Product Code
HGL
Transducer, Ultrasonic, Obstetric
2
Product Code
HGM
System, Monitoring, Perinatal
2
Product Code
HGN
Stethoscope, Fetal
1
Product Code
HGO
Monitor, Electroencephalographic, Fetal (And Accessories)
3
Product Code
HGP
Electrode, Circular (Spiral), Scalp And Applicator
2
Product Code
HGS
Catheter, Intrauterine And Introducer
2
Product Code
HHJ
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
2
Product Code
HHX
Holograph, Fetal, Acoustical
2
Product Code
HIQ
Electrode, Clip, Fetal Scalp (And Applicator)
3
Product Code
KNG
Monitor, Ultrasonic, Fetal
2
Product Code
KXN
Monitor, Cardiac, Fetal
2
Product Code
KXO
Monitor, Pressure, Intrauterine
2
Product Code
LQK
Home Uterine Activity Monitor
2
Product Code
MOH
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
2
Product Code
NHM
Sheet, Recording, Breast Examination
2
Product Code
NKA
System, Documentation, Breast Lesion
2
Product Code
OSP
Uterine Electromyographic Monitor
2
Product Code
NPB
System, Monitoring, For Progress Of Labor
2
Product Code
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
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
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HFM
/
K843011
View Source
TERM GUARD 5000 UTERINE ACTIVITY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843011
510(k) Type
Traditional
Applicant
TOKOS MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/1984
Days to Decision
93 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
HEQ
Monitor, Pressure, Arterial, Fetal, Ultrasonic
HEI
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
HEJ
Monitor, Hemic Sound, Ultrasonic
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
HEM
Imager, Ultrasonic Obstetric-Gynecologic
HEN
Caliper, Fetal Head, Ultrasonic
HEO
Analyzer, Data, Obstetric
HEP
Monitor, Blood-Flow, Ultrasonic
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
K
14
0163
KOALA TOCO
K
06
1044
FEATHERLITE AQUA TOCODYNAMOMETER
K
04
0392
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K
01
3477
TOCO LITE, MODEL TD-01
K
99
4353
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K
99
2811
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K
95
4847
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
K
95
2579
TOCO TRANSDUCER
K
92
0152
BUBBLE TOCO
K
91
0282
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
P
89
0063
GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)
P
89
0063
GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
P
89
0063
GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.
K
90
4691
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST
K
90
3623
MODEL600 UTERINE ACTIVITY MONITOR
K
90
2104
ORION WATCHGUARD
P
89
0063
GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
K
89
4030
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K
89
3770
TERM GUARD II DEVICE
K
89
1997
CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER
K
88
2080
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
K
87
4631
HEALTHPHONE TOCO MODEL
K
87
3150
PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
K
86
0933
AIR-CUSHION TOCOTONOMETER
K
85
3856
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
K
84
3011
TERM GUARD 5000 UTERINE ACTIVITY
K
84
0747
TOCO DATA TELEPHONE TRANSMITTER DT100P
HFN
Transducer, Pressure, Intrauterine
HFO
Recorder, Pressure, Intrauterine
HFP
Monitor, Phonocardiographic, Fetal
HGL
Transducer, Ultrasonic, Obstetric
HGM
System, Monitoring, Perinatal
HGN
Stethoscope, Fetal
HGO
Monitor, Electroencephalographic, Fetal (And Accessories)
HGP
Electrode, Circular (Spiral), Scalp And Applicator
HGS
Catheter, Intrauterine And Introducer
HHJ
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
HHX
Holograph, Fetal, Acoustical
HIQ
Electrode, Clip, Fetal Scalp (And Applicator)
KNG
Monitor, Ultrasonic, Fetal
KXN
Monitor, Cardiac, Fetal
KXO
Monitor, Pressure, Intrauterine
LQK
Home Uterine Activity Monitor
MOH
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
NHM
Sheet, Recording, Breast Examination
NKA
System, Documentation, Breast Lesion
OSP
Uterine Electromyographic Monitor
NPB
System, Monitoring, For Progress Of Labor
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HFM
/
K843011
View Source
TERM GUARD 5000 UTERINE ACTIVITY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843011
510(k) Type
Traditional
Applicant
TOKOS MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/1984
Days to Decision
93 days