Device Classification Name |
Electrode, Electrocardiograph
|
510(k) Number |
K790305 |
Device Name |
ELECTRODES, FERRIS ECG, TYPES 905,906 |
Applicant |
FERRIS MFG. CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
FERRIS MFG. CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.2360 |
Classification Product Code |
|
Date Received | 02/13/1979 |
Decision Date | 04/03/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|