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
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
PDQ
Neurosurgical Nerve Locator
2
Product Code
HRW
Dynamometer, Nonpowered
1
Product Code
KQW
Goniometer, Nonpowered
1
Product Code
K
92
6237
O'BRIEN GONIOMETER
1
Cleared 510(K)
K
90
1744
DOBBHOFF(R) RETRIEVAL FORCEPS
1
Cleared 510(K)
K
87
0767
THE (CROM) TESTER
1
Cleared 510(K)
K
85
0082
HAND HELD GONIOMETER
1
Cleared 510(K)
K
83
1550
FINGER BONIOMETER BK7506
1
Cleared 510(K)
K
81
2778
THE TELOS EQUIPMENT
1
Cleared 510(K)
K
81
0441
UNIVERSAL GONIMETER
1
Cleared 510(K)
K
80
1718
BK-7513 STAINLESS STEEL GONIOMETER
1
Cleared 510(K)
K
80
1715
BK-7497 BULB DYNAMOMETER
1
Cleared 510(K)
K
80
1716
BK-7505 RADIOPAQUE GONIOMETER, 8
1
Cleared 510(K)
Show All 13 Submissions
KQX
Goniometer, Ac-Powered
1
Product Code
LBB
Dynamometer, Ac-Powered
2
Product Code
NKI
Goniometer With Electrodes
2
Product Code
QWP
Optical Neurosurgical Nerve Locator
2
Product Code
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
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 6 December 2024 at 11:05 pm
NE
/
subpart-b—diagnostic-devices
/
KQW
/
K810441
View Source
UNIVERSAL GONIMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K810441
510(k) Type
Traditional
Applicant
FRED SAMMONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/27/1981
Days to Decision
8 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
PDQ
Neurosurgical Nerve Locator
HRW
Dynamometer, Nonpowered
KQW
Goniometer, Nonpowered
K
92
6237
O'BRIEN GONIOMETER
K
90
1744
DOBBHOFF(R) RETRIEVAL FORCEPS
K
87
0767
THE (CROM) TESTER
K
85
0082
HAND HELD GONIOMETER
K
83
1550
FINGER BONIOMETER BK7506
K
81
2778
THE TELOS EQUIPMENT
K
81
0441
UNIVERSAL GONIMETER
K
80
1718
BK-7513 STAINLESS STEEL GONIOMETER
K
80
1715
BK-7497 BULB DYNAMOMETER
K
80
1716
BK-7505 RADIOPAQUE GONIOMETER, 8
Show All 13 Submissions
KQX
Goniometer, Ac-Powered
LBB
Dynamometer, Ac-Powered
NKI
Goniometer With Electrodes
QWP
Optical Neurosurgical Nerve Locator
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—diagnostic-devices
/
KQW
/
K810441
View Source
UNIVERSAL GONIMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K810441
510(k) Type
Traditional
Applicant
FRED SAMMONS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/27/1981
Days to Decision
8 days