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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
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Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
NUW
Stimulator, Muscle, Powered, Dental
2
Product Code
K
20
3525
D function
2
Cleared 510(K)
K
04
0400
MYO-TRODE SG DISPOSABLE ELECTRODE
2
Cleared 510(K)
K
03
1998
MODEL J-5 MVO-MONITOR
2
Cleared 510(K)
K
90
1902
ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
2
Cleared 510(K)
K
89
0143
ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON
2
Cleared 510(K)
K
84
2223
J4 MYO-MONITOR
2
Cleared 510(K)
K
84
2224
BNS 40
2
Cleared 510(K)
K
77
0252
MONITOR, MYO, MODEL J3
2
Cleared 510(K)
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
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
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
DE
/
subpart-f—physical-medicine-therapeutic-devices
/
NUW
/
K040400
View Source
MYO-TRODE SG DISPOSABLE ELECTRODE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040400
510(k) Type
Traditional
Applicant
MYOTRONICS-NOROMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2004
Days to Decision
154 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
NUW
Stimulator, Muscle, Powered, Dental
K
20
3525
D function
K
04
0400
MYO-TRODE SG DISPOSABLE ELECTRODE
K
03
1998
MODEL J-5 MVO-MONITOR
K
90
1902
ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
K
89
0143
ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON
K
84
2223
J4 MYO-MONITOR
K
84
2224
BNS 40
K
77
0252
MONITOR, MYO, MODEL J3
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-f—physical-medicine-therapeutic-devices
/
NUW
/
K040400
View Source
MYO-TRODE SG DISPOSABLE ELECTRODE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040400
510(k) Type
Traditional
Applicant
MYOTRONICS-NOROMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2004
Days to Decision
154 days
Submission Type
Summary