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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
HFN
Transducer, Pressure, Intrauterine
2
Product Code
K
97
4389
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
2
Cleared 510(K)
K
97
3746
PRE-FILLED SYRINGE FOR KOALA IUP
2
Cleared 510(K)
K
96
1424
INTRAN 500
2
Cleared 510(K)
K
95
4955
STORC INTRAUTERINE PRESSURE CATHETER
2
Cleared 510(K)
K
95
5443
INTRAN PLUS
2
Cleared 510(K)
K
92
0375
DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER
2
Cleared 510(K)
K
88
2224
ULTRANS DISPOSABLE INTRAUTERINE
2
Cleared 510(K)
K
89
3503
SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS
2
Cleared 510(K)
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
/
HFN
/
K974389
View Source
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974389
510(k) Type
Traditional
Applicant
CLINICAL INNOVATIONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/1998
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
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)
HFN
Transducer, Pressure, Intrauterine
K
97
4389
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
K
97
3746
PRE-FILLED SYRINGE FOR KOALA IUP
K
96
1424
INTRAN 500
K
95
4955
STORC INTRAUTERINE PRESSURE CATHETER
K
95
5443
INTRAN PLUS
K
92
0375
DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER
K
88
2224
ULTRANS DISPOSABLE INTRAUTERINE
K
89
3503
SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS
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
/
HFN
/
K974389
View Source
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974389
510(k) Type
Traditional
Applicant
CLINICAL INNOVATIONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/19/1998
Days to Decision
90 days
Submission Type
Summary