The following data is part of a premarket notification filed by Oceania Health Care Systems, Inc. with the FDA for Oceania Health Care Systems Electronic Medical Rec.
| Device ID | K921846 |
| 510k Number | K921846 |
| Device Name: | OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC |
| Classification | Medical Computers And Software |
| Applicant | OCEANIA HEALTH CARE SYSTEMS, INC. 325 LYTTON AVE. SUITE 400 Palo Alto, CA 94302 |
| Contact | Richard M Peters |
| Correspondent | Richard M Peters OCEANIA HEALTH CARE SYSTEMS, INC. 325 LYTTON AVE. SUITE 400 Palo Alto, CA 94302 |
| Product Code | LNX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1994-08-08 |