| 510(k) Number |
K921846 |
| Device Name |
OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC |
| Applicant |
| Oceania Health Care Systems, Inc. |
| 325 Lytton Ave. |
| Suite 400 |
|
Palo Alto,
CA
94302
|
|
| Applicant Contact |
RICHARD M PETERS |
| Correspondent |
| Oceania Health Care Systems, Inc. |
| 325 Lytton Ave. |
| Suite 400 |
|
Palo Alto,
CA
94302
|
|
| Correspondent Contact |
RICHARD M PETERS |
| Classification Product Code |
|
| Date Received | 04/17/1992 |
| Decision Date | 08/08/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|