Device Classification Name |
probe, thermodilution
|
510(k) Number |
K991886 |
Device Name |
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR |
Applicant |
PULSION MEDICAL SYSTEMS, INC. |
8911 SEDGLEY DR. |
WILMINGTON,
NC
28412
|
|
Applicant Contact |
ULF BORG |
Correspondent |
PULSION MEDICAL SYSTEMS, INC. |
8911 SEDGLEY DR. |
WILMINGTON,
NC
28412
|
|
Correspondent Contact |
ULF BORG |
Regulation Number | 870.1915
|
Classification Product Code |
|
Date Received | 06/02/1999 |
Decision Date | 05/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|