The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Q2 Plus S02/continuous Cardiac Output Computer, List Number 56711.
| Device ID | K021874 |
| 510k Number | K021874 |
| Device Name: | ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 -6157 |
| Contact | Frank Pokrop |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-06-07 |
| Decision Date | 2002-07-12 |
| Summary: | summary |