Device Classification Name |
device, muscle monitoring
|
510(k) Number |
K921919 |
Device Name |
MS-100 MYO-SCANNER OR MS-100 EMG SCANNER |
Applicant |
MYO-TRONICS, INC. |
720 OLIVE WAY |
SUITE 800 |
SEATTLE,
WA
98101
|
|
Applicant Contact |
ADIB |
Correspondent |
MYO-TRONICS, INC. |
720 OLIVE WAY |
SUITE 800 |
SEATTLE,
WA
98101
|
|
Correspondent Contact |
ADIB |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 04/23/1992 |
Decision Date | 01/07/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|