Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K801762 |
Device Name |
MICRO-PROCESSOR UNIT #A3600AC |
Applicant |
GENERAL ELECTRIC CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GENERAL ELECTRIC CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 07/28/1980 |
Decision Date | 08/27/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|