Device Classification Name |
Electrocardiograph
|
510(k) Number |
K811949 |
Device Name |
KENL-ECG-3 |
Applicant |
SUZUKEN CO., LTD. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SUZUKEN CO., LTD. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 07/07/1981 |
Decision Date | 08/13/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|