Device Classification Name |
Electrocardiograph
|
510(k) Number |
K790794 |
Device Name |
SIEMENS CARDIOSTAT 701 |
Applicant |
ELMED, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ELMED, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 04/24/1979 |
Decision Date | 05/31/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|