The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Cardiac Output Computer.
| Device ID | K831967 |
| 510k Number | K831967 |
| Device Name: | CRITIKON CARDIAC OUTPUT COMPUTER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-20 |
| Decision Date | 1983-10-28 |