Device Classification Name |
dynamometer, ac-powered
|
510(k) Number |
K980363 |
Device Name |
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) |
Applicant |
OROFACIAL DYNAMICS |
PO BOX 1082 |
ALAMO,
CA
94507
|
|
Applicant Contact |
RONALD E TURA |
Correspondent |
OROFACIAL DYNAMICS |
PO BOX 1082 |
ALAMO,
CA
94507
|
|
Correspondent Contact |
RONALD E TURA |
Regulation Number | 888.1240
|
Classification Product Code |
|
Date Received | 01/29/1998 |
Decision Date | 04/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|