Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K083384 |
Device Name |
THERMODILUTION CATHETER |
Applicant |
BIOSENSORS INTL. PTE. LTD. |
21 KALLANG AVENUE #07-167 |
SINGAPORE,
SG
339412
|
|
Applicant Contact |
MOSES THAM |
Correspondent |
BIOSENSORS INTL. PTE. LTD. |
21 KALLANG AVENUE #07-167 |
SINGAPORE,
SG
339412
|
|
Correspondent Contact |
MOSES THAM |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 11/17/2008 |
Decision Date | 01/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|