| Device Classification Name |
Transducer, Pressure, Catheter Tip
|
| 510(k) Number |
K880830 |
| Device Name |
SENTORR ARTERIAL PRESSURE SENSOR |
| Applicant |
| Ohmeda Medical |
| 2007 Pan Am Cir. |
|
Tampa,
FL
33702
|
|
| Applicant Contact |
JILL PHILLIPS |
| Correspondent |
| Ohmeda Medical |
| 2007 Pan Am Cir. |
|
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|