The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Continuous Cardiac Output System.
| Device ID | K932414 |
| 510k Number | K932414 |
| Device Name: | CONTINUOUS CARDIAC OUTPUT SYSTEM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Frederick Gustafson |
| Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-19 |
| Decision Date | 1994-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840619060265 | K932414 | 000 |
| 10840619060241 | K932414 | 000 |