The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Cardiac Output Computer.
| Device ID | K831407 |
| 510k Number | K831407 |
| Device Name: | CARDIAC OUTPUT COMPUTER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | ZIEHM INTERNATIONAL, INC. 906-A COMMERCE RD. Annapolis, MD 21401 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-02 |
| Decision Date | 1983-10-14 |