The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Recomed Cardiac Output Meter 236067-.
| Device ID | K840439 |
| 510k Number | K840439 |
| Device Name: | RECOMED CARDIAC OUTPUT METER 236067- |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Contact | Robert L Casarsa |
| Correspondent | Robert L Casarsa LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-11-20 |