The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Mtc 6210a Cardiac Output Computer.
| Device ID | K854371 |
| 510k Number | K854371 |
| Device Name: | MTC 6210A CARDIAC OUTPUT COMPUTER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Dennis Javens |
| Correspondent | Dennis Javens NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1987-02-19 |