Device Classification Name |
electrode, electrocardiograph
|
510(k) Number |
K833695 |
Device Name |
ADULT MONITORING ELECTOR@@RODE 9431-300 |
Applicant |
MARQUETTE ELECTRONICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MARQUETTE ELECTRONICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.2360
|
Classification Product Code |
|
Date Received | 10/18/1983 |
Decision Date | 01/27/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|