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
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
IKN
Electromyograph, Diagnostic
2
Product Code
K
17
2743
Natus VikingQuest
2
Cleared 510(K)
K
16
3150
ViMove2
2
Cleared 510(K)
K
16
2383
Cadwell Sierra Summit, Cadwell Sierra Ascent
2
Cleared 510(K)
K
14
2494
ViMove
2
Cleared 510(K)
K
13
1094
VIMOVE
2
Cleared 510(K)
K
12
3902
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
2
Cleared 510(K)
K
12
3399
MYOVISION 3.0 WIREFREE SYSTEM
2
Cleared 510(K)
K
11
3074
CMAP PRO
2
Cleared 510(K)
K
10
2610
FOCUS EMG DEVICE
2
Cleared 510(K)
K
11
0048
CERSR ELECTROMYOGRAPHY SYSTEM
2
Cleared 510(K)
Show All 73 Submissions
IKT
Electrode, Needle, Diagnostic Electromyograph
2
Product Code
LYH
Arthrometer
1
Product Code
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 20 December 2024 at 11:05 pm
NE
/
subpart-b—physical-medicine-diagnostic-devices
/
IKN
/
K102610
View Source
FOCUS EMG DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102610
510(k) Type
Traditional
Applicant
TELEEMG, LLC USA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/2011
Days to Decision
175 days
Submission Type
Summary
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
K
17
2743
Natus VikingQuest
K
16
3150
ViMove2
K
16
2383
Cadwell Sierra Summit, Cadwell Sierra Ascent
K
14
2494
ViMove
K
13
1094
VIMOVE
K
12
3902
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
K
12
3399
MYOVISION 3.0 WIREFREE SYSTEM
K
11
3074
CMAP PRO
K
10
2610
FOCUS EMG DEVICE
K
11
0048
CERSR ELECTROMYOGRAPHY SYSTEM
Show All 73 Submissions
IKT
Electrode, Needle, Diagnostic Electromyograph
LYH
Arthrometer
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
/
IKN
/
K102610
View Source
FOCUS EMG DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102610
510(k) Type
Traditional
Applicant
TELEEMG, LLC USA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/2011
Days to Decision
175 days
Submission Type
Summary