Device Classification Name |
Stimulator, Muscle, Powered, Dental
|
510(k) Number |
K842223 |
Device Name |
J4 MYO-MONITOR |
Applicant |
MYO-TRONICS RESEARCH, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Applicant Contact |
FRAY ADIB |
Correspondent |
MYO-TRONICS RESEARCH, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent Contact |
FRAY ADIB |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 06/05/1984 |
Decision Date | 11/19/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|