The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Mlc-4200 Cardiac Output Computer.
| Device ID | K802305 |
| 510k Number | K802305 |
| Device Name: | MLC-4200 CARDIAC OUTPUT COMPUTER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-10-10 |