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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
K
10
1960
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
2
Cleared 510(K)
K
02
3082
BABYCARE
2
Cleared 510(K)
K
92
0353
ULTRACELL INSTRUMENT WIPE
2
Cleared 510(K)
K
91
0462
POCKET DOP 3
2
Cleared 510(K)
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
2
Product Code
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
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Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HEP
/
K920353
View Source
ULTRACELL INSTRUMENT WIPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K920353
510(k) Type
Traditional
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/15/1992
Days to Decision
232 days
Submission Type
Statement
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
K
10
1960
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
K
02
3082
BABYCARE
K
92
0353
ULTRACELL INSTRUMENT WIPE
K
91
0462
POCKET DOP 3
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
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
/
HEP
/
K920353
View Source
ULTRACELL INSTRUMENT WIPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K920353
510(k) Type
Traditional
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/15/1992
Days to Decision
232 days
Submission Type
Statement