Device Classification Name |
computer, diagnostic, pre-programmed, single-function
|
510(k) Number |
K760192 |
Device Name |
COMPUTER, THERMODILUTION CARDIAC (9520) |
Applicant |
EDWARDS LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
EDWARDS LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1435
|
Classification Product Code |
|
Date Received | 07/06/1976 |
Decision Date | 07/19/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|