The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Ecom Endotracheal Cardiac Output Monitor System.
| Device ID | K131765 |
| 510k Number | K131765 |
| Device Name: | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM |
| Classification | Plethysmograph, Impedance |
| Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Contact | Lisa Anderson |
| Correspondent | Lisa Anderson CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-12-20 |
| Summary: | summary |