The following data is part of a premarket notification filed by J-f Medical Systems Intl., Inc. with the FDA for Omega Cares System.
| Device ID | K945068 |
| 510k Number | K945068 |
| Device Name: | OMEGA CARES SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | J-F MEDICAL SYSTEMS INTL., INC. 2440 LACY LN., SUITE 101 Carrollton, TX 75006 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer J-F MEDICAL SYSTEMS INTL., INC. 2440 LACY LN., SUITE 101 Carrollton, TX 75006 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1996-01-25 |