Device Classification Name |
Device, Muscle Monitoring
|
510(k) Number |
K922456 |
Device Name |
K6-I DIAGNOSTIC SYSTEM |
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 |
|
Subsequent Product Code |
|
Date Received | 05/26/1992 |
Decision Date | 06/09/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|