Device Classification Name |
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
|
510(k) Number |
K020967 |
Device Name |
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
1311 VALENCIA AVE. |
TUSTIN,
CA
92780
|
|
Applicant Contact |
STEVE ARICK |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
1311 VALENCIA AVE. |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
STEVE ARICK |
Regulation Number | 868.1170
|
Classification Product Code |
|
Date Received | 03/25/2002 |
Decision Date | 06/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|