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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
HFO
Recorder, Pressure, Intrauterine
2
Product Code
HFP
Monitor, Phonocardiographic, Fetal
2
Product Code
HGL
Transducer, Ultrasonic, Obstetric
2
Product Code
K
95
2031
ULTRASOUND TRANSDUCER, MODEL US917
2
Cleared 510(K)
K
92
3335
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
2
Cleared 510(K)
K
92
4516
OP3/VP4
2
Cleared 510(K)
K
90
3348
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
2
Cleared 510(K)
K
90
0966
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
2
Cleared 510(K)
K
90
3316
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
2
Cleared 510(K)
K
90
1142
MER MULTIPLANE VAGINAL PROBE (MVP)
2
Cleared 510(K)
K
90
0838
TRANSVAGINAL TRANSDUCER ASSEMBLY
2
Cleared 510(K)
K
89
5449
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
2
Cleared 510(K)
K
88
1263
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
2
Cleared 510(K)
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
K
89
5647
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
2
Cleared 510(K)
P
80
0016
YENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
K
89
5123
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
2
Cleared 510(K)
K
89
5026
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
2
Cleared 510(K)
K
89
4415
DYMAX ENDOVAGINAL BIOPSY GUIDE
2
Cleared 510(K)
K
89
2070
GENERAL IVT NEEDLE GUIDE KIT, STERILE
2
Cleared 510(K)
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
K
88
1405
SIEMENS INTRAVAGINAL TRANSDUCER
2
Cleared 510(K)
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
K
87
5371
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
2
Cleared 510(K)
K
87
5334
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
2
Cleared 510(K)
K
87
2265
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
2
Cleared 510(K)
K
87
1856
ANNULAR ARRAY SCANHEAD
2
Cleared 510(K)
K
87
0709
7.5 MHZ ENDOVAGINAL PROBE
2
Cleared 510(K)
K
86
4908
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
2
Cleared 510(K)
K
86
4578
ACUSON TV519 TRANSDUCER
2
Cleared 510(K)
K
86
4219
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
2
Cleared 510(K)
K
86
4151
280SL IMAGING SYSTEM TRANVAGINAL PROBES
2
Cleared 510(K)
K
86
3797
BIOPSY NEEDLE GUIDE ATTACHMENT
2
Cleared 510(K)
K
86
1371
TRANSVAGINAL PROBE, MODEL ED65M-TV
2
Cleared 510(K)
K
86
2072
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
2
Cleared 510(K)
K
86
1577
ACUSON S228, S519 & L558 TRANSDUCERS
2
Cleared 510(K)
K
86
1578
ACUSON S328, L382, L538 & L312 TRANSDUCERS
2
Cleared 510(K)
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
K
86
0234
TRANSVAGINAL TRANSDUCER, 5MHZ
2
Cleared 510(K)
K
86
0621
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
2
Cleared 510(K)
K
86
0313
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
2
Cleared 510(K)
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
2
PMA Approval
K
82
7885
BIO-DERM COUPLING LOTION
2
Cleared 510(K)
K
77
1869
DIAG. ULTRASOUND B-SCANNER
2
Cleared 510(K)
K
77
1151
ARTIUS SYSTEM
2
Cleared 510(K)
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 20 December 2024 at 11:05 pm
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HGL
/
K895026
View Source
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
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
HFO
Recorder, Pressure, Intrauterine
HFP
Monitor, Phonocardiographic, Fetal
HGL
Transducer, Ultrasonic, Obstetric
K
95
2031
ULTRASOUND TRANSDUCER, MODEL US917
K
92
3335
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
K
92
4516
OP3/VP4
K
90
3348
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K
90
0966
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K
90
3316
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K
90
1142
MER MULTIPLANE VAGINAL PROBE (MVP)
K
90
0838
TRANSVAGINAL TRANSDUCER ASSEMBLY
K
89
5449
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K
88
1263
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
K
89
5647
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
P
80
0016
YENNANT(TM) & KELMAN(TM) TYPE II
K
89
5123
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K
89
5026
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K
89
4415
DYMAX ENDOVAGINAL BIOPSY GUIDE
K
89
2070
GENERAL IVT NEEDLE GUIDE KIT, STERILE
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
K
88
1405
SIEMENS INTRAVAGINAL TRANSDUCER
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
K
87
5371
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K
87
5334
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K
87
2265
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
K
87
1856
ANNULAR ARRAY SCANHEAD
K
87
0709
7.5 MHZ ENDOVAGINAL PROBE
K
86
4908
DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE
K
86
4578
ACUSON TV519 TRANSDUCER
K
86
4219
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
K
86
4151
280SL IMAGING SYSTEM TRANVAGINAL PROBES
K
86
3797
BIOPSY NEEDLE GUIDE ATTACHMENT
K
86
1371
TRANSVAGINAL PROBE, MODEL ED65M-TV
K
86
2072
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
K
86
1577
ACUSON S228, S519 & L558 TRANSDUCERS
K
86
1578
ACUSON S328, L382, L538 & L312 TRANSDUCERS
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
K
86
0234
TRANSVAGINAL TRANSDUCER, 5MHZ
K
86
0621
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
K
86
0313
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
P
80
0016
TENNANT(TM) & KELMAN(TM) TYPE II
K
82
7885
BIO-DERM COUPLING LOTION
K
77
1869
DIAG. ULTRASOUND B-SCANNER
K
77
1151
ARTIUS SYSTEM
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
/
HGL
/
K895026
View Source
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...