| Device Classification Name |
Oximeter
|
| 510(k) Number |
K914538 |
| Device Name |
UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER |
| Applicant |
| Innovative Medical Products, Inc. |
| 825 Roseland Pkwy. |
|
Hrahan,
LA
70123
|
|
| Applicant Contact |
CHARLES D MAYEUX |
| Correspondent |
| Innovative Medical Products, Inc. |
| 825 Roseland Pkwy. |
|
Hrahan,
LA
70123
|
|
| Correspondent Contact |
CHARLES D MAYEUX |
| Regulation Number | 870.2700 |
| Classification Product Code |
|
| Date Received | 10/11/1991 |
| Decision Date | 07/14/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|