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Innolitics
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Review Panel
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Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
IKN
Electromyograph, Diagnostic
2
Product Code
IKT
Electrode, Needle, Diagnostic Electromyograph
2
Product Code
LYH
Arthrometer
1
Product Code
K
94
3197
KT1000/S KNEE LIGAMENT ARTHROMETER
1
Cleared 510(K)
K
94
2059
KT2000 KNEE LIGAMENT ARTHROMETER
1
Cleared 510(K)
K
88
1876
DYNAMIC CRUCIATE TESTER
1
Cleared 510(K)
K
83
4462
GENUCOM
1
Cleared 510(K)
K
81
2806
KT-1000 DEVICE
1
Cleared 510(K)
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—physical-medicine-diagnostic-devices
/
LYH
/
K881876
View Source
DYNAMIC CRUCIATE TESTER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K881876
510(k) Type
Traditional
Applicant
DYONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/17/1988
Days to Decision
197 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
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
IKN
Electromyograph, Diagnostic
IKT
Electrode, Needle, Diagnostic Electromyograph
LYH
Arthrometer
K
94
3197
KT1000/S KNEE LIGAMENT ARTHROMETER
K
94
2059
KT2000 KNEE LIGAMENT ARTHROMETER
K
88
1876
DYNAMIC CRUCIATE TESTER
K
83
4462
GENUCOM
K
81
2806
KT-1000 DEVICE
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—physical-medicine-diagnostic-devices
/
LYH
/
K881876
View Source
DYNAMIC CRUCIATE TESTER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K881876
510(k) Type
Traditional
Applicant
DYONICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/17/1988
Days to Decision
197 days