The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Cardiac Output Option 39.
| Device ID | K943256 |
| 510k Number | K943256 |
| Device Name: | CARDIAC OUTPUT OPTION 39 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | Jim Rooks |
| Correspondent | Jim Rooks MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1994-12-15 |