Device Classification Name |
Probe, Thermodilution
|
510(k) Number |
K760067 |
Device Name |
CATHETER, THERMAL DILUTION, OPEN CHEST |
Applicant |
INSTRUMENTATION LABORATORY CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INSTRUMENTATION LABORATORY CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1915
|
Classification Product Code |
|
Date Received | 06/16/1976 |
Decision Date | 07/21/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|