Device Classification Name |
exerciser, measuring
|
510(k) Number |
K834098 |
Device Name |
STATIONARY EXERCISE BICYCLE |
Applicant |
ENGINEERING DYNAMICS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ENGINEERING DYNAMICS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 890.5360
|
Classification Product Code |
|
Date Received | 11/28/1983 |
Decision Date | 12/27/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|