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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
K
97
1407
JTECH COMMANDER AND ALGOMETER
1
Cleared 510(K)
K
97
0870
DIGIT-GRIP WITH LCD (DGR002)
1
Cleared 510(K)
K
89
4557
LIGHTSCOPE SET
1
Cleared 510(K)
K
86
1396
HANDHELD DYNAMOMETER, MODEL #160 AND #111
1
Cleared 510(K)
K
82
1631
PINCH GAUGE, 0-301 LBS.
1
Cleared 510(K)
K
81
2343
PINCH METER
1
Cleared 510(K)
K
80
1719
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG
1
Cleared 510(K)
K
79
1021
MUSCLE TESTING GUN
1
Cleared 510(K)
K
79
0302
PRESSURE MONITOR, MODEL 212
1
Cleared 510(K)
K
77
2415
DYNAMETER 50 LB.
1
Cleared 510(K)
Show All 12 Submissions
KQW
Goniometer, Nonpowered
1
Product Code
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 16 August 2024 at 11:05 pm
NE
/
subpart-b—diagnostic-devices
/
HRW
/
K894557
View Source
LIGHTSCOPE SET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894557
510(k) Type
Traditional
Applicant
OPTIK
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/7/1989
Days to Decision
18 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
K
97
1407
JTECH COMMANDER AND ALGOMETER
K
97
0870
DIGIT-GRIP WITH LCD (DGR002)
K
89
4557
LIGHTSCOPE SET
K
86
1396
HANDHELD DYNAMOMETER, MODEL #160 AND #111
K
82
1631
PINCH GAUGE, 0-301 LBS.
K
81
2343
PINCH METER
K
80
1719
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG
K
79
1021
MUSCLE TESTING GUN
K
79
0302
PRESSURE MONITOR, MODEL 212
K
77
2415
DYNAMETER 50 LB.
Show All 12 Submissions
KQW
Goniometer, Nonpowered
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
/
HRW
/
K894557
View Source
LIGHTSCOPE SET
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894557
510(k) Type
Traditional
Applicant
OPTIK
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/7/1989
Days to Decision
18 days