Device Classification Name |
transducer, pressure, catheter tip
|
510(k) Number |
K880830 |
Device Name |
SENTORR ARTERIAL PRESSURE SENSOR |
Applicant |
OHMEDA MEDICAL |
2007 PAN AM CIRCLE |
TAMPA,
FL
33702
|
|
Applicant Contact |
JILL PHILLIPS |
Correspondent |
OHMEDA MEDICAL |
2007 PAN AM CIRCLE |
TAMPA,
FL
33702
|
|
Correspondent Contact |
JILL PHILLIPS |
Regulation Number | 870.2870
|
Classification Product Code |
|
Date Received | 03/01/1988 |
Decision Date | 08/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|