The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Cardiac Output Computer.
| Device ID | K844682 |
| 510k Number | K844682 |
| Device Name: | ELECATH CARDIAC OUTPUT COMPUTER |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Contact | Silpe |
| Correspondent | Silpe ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-30 |
| Decision Date | 1985-03-06 |