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Hematology
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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
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
2
Product Code
HET
Laparoscope, Gynecologic (And Accessories)
2
Product Code
HEW
Culdoscope (And Accessories)
2
Product Code
HEX
Colposcope (And Colpomicroscope)
2
Product Code
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
2
Product Code
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
F
Product Code
HFC
Aspirator, Endocervical
2
Product Code
K
97
4032
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
2
Cleared 510(K)
K
96
0263
CERVICAL MUCOUS ASPIRATION CATHETER
2
Cleared 510(K)
K
95
4903
PEDI VAGINAL ASPIRATOR
2
Cleared 510(K)
K
95
4102
SELECTMUCUS
2
Cleared 510(K)
K
90
2242
ENDOCERVICAL ASPIRATOR
2
Cleared 510(K)
K
90
2032
O. B. PACK IV
2
Cleared 510(K)
K
90
2954
OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
2
Cleared 510(K)
K
89
5403
ASPIRETTE ENDOCERVICAL ASPIRATOR
2
Cleared 510(K)
K
82
1134
DC PACK TM
2
Cleared 510(K)
K
81
2175
ENDOCERVICAL ASPIRATOR
2
Cleared 510(K)
Show All 11 Submissions
HFD
Washer, Endometrial
2
Product Code
HFE
Brush, Endometrial
2
Product Code
HFF
Aspirator, Endometrial
2
Product Code
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
2
Product Code
HGW
Sampler, Blood, Fetal
2
Product Code
HHK
Curette, Suction, Endometrial (And Accessories)
2
Product Code
HIF
Insufflator, Laparoscopic
2
Product Code
HIG
Insufflator, Hysteroscopic
2
Product Code
HIH
Hysteroscope (And Accessories)
2
Product Code
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
1
Product Code
LHZ
Viscometer, Mucus, Cervical
1
Product Code
MKO
Falloposcope
2
Product Code
MOK
Vaginoscope And Accessories
2
Product Code
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
1
Product Code
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
2
Product Code
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
1
Product Code
NVT
Tubing And Tubing/Filter Fits
1
Product Code
NWV
Laparoscopic Accessories, Gynecologic
1
Product Code
NWW
Hysteroscope Accessories
1
Product Code
PCF
Sampler, Endocervical
2
Product Code
OHD
Gynecological Laparoscopic Kit
2
Product Code
OHE
Forensic Evidence Sexual Assault Kit
2
Product Code
OHF
Culdocentesis Kit
2
Product Code
OHM
Cesarean Section Tray
2
Product Code
OKX
Trocar Kit
2
Product Code
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
2
Product Code
OKZ
Endometrial Sampling Kit
2
Product Code
OSV
Insufflator, Endoscopic Vessel Harvesting
2
Product Code
PTZ
Colposcope (And Colpomicroscope), Exempt
2
Product Code
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
2
Product Code
QHZ
Seal, Cervical, Mechanical, Unpowered
1
Product Code
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
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 30 November 2024 at 11:09 am
OB
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
HFC
/
K902954
View Source
OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902954
510(k) Type
Traditional
Applicant
PERMOBIL A.B.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/23/1990
Days to Decision
49 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
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
HET
Laparoscope, Gynecologic (And Accessories)
HEW
Culdoscope (And Accessories)
HEX
Colposcope (And Colpomicroscope)
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
HFC
Aspirator, Endocervical
K
97
4032
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
K
96
0263
CERVICAL MUCOUS ASPIRATION CATHETER
K
95
4903
PEDI VAGINAL ASPIRATOR
K
95
4102
SELECTMUCUS
K
90
2242
ENDOCERVICAL ASPIRATOR
K
90
2032
O. B. PACK IV
K
90
2954
OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
K
89
5403
ASPIRETTE ENDOCERVICAL ASPIRATOR
K
82
1134
DC PACK TM
K
81
2175
ENDOCERVICAL ASPIRATOR
Show All 11 Submissions
HFD
Washer, Endometrial
HFE
Brush, Endometrial
HFF
Aspirator, Endometrial
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
HGW
Sampler, Blood, Fetal
HHK
Curette, Suction, Endometrial (And Accessories)
HIF
Insufflator, Laparoscopic
HIG
Insufflator, Hysteroscopic
HIH
Hysteroscope (And Accessories)
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
LHZ
Viscometer, Mucus, Cervical
MKO
Falloposcope
MOK
Vaginoscope And Accessories
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
NVT
Tubing And Tubing/Filter Fits
NWV
Laparoscopic Accessories, Gynecologic
NWW
Hysteroscope Accessories
PCF
Sampler, Endocervical
OHD
Gynecological Laparoscopic Kit
OHE
Forensic Evidence Sexual Assault Kit
OHF
Culdocentesis Kit
OHM
Cesarean Section Tray
OKX
Trocar Kit
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
OKZ
Endometrial Sampling Kit
OSV
Insufflator, Endoscopic Vessel Harvesting
PTZ
Colposcope (And Colpomicroscope), Exempt
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
QHZ
Seal, Cervical, Mechanical, Unpowered
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
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-b—obstetrical-and-gynecological-diagnostic-devices
/
HFC
/
K902954
View Source
OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902954
510(k) Type
Traditional
Applicant
PERMOBIL A.B.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/23/1990
Days to Decision
49 days