The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Cardiac Output Computer W/hemodynamic.
| Device ID | K844116 |
| 510k Number | K844116 |
| Device Name: | CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
| Contact | Melanie Sabo |
| Correspondent | Melanie Sabo CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 22800 Tampa, FL 33630 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-05-28 |