The following data is part of a premarket notification filed by Imagyn Surgical with the FDA for Ecom Endotrachial Cardiac Output Monitor.
| Device ID | K021174 |
| 510k Number | K021174 |
| Device Name: | ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR |
| Classification | Plethysmograph, Impedance |
| Applicant | IMAGYN SURGICAL 8850 M-89 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell IMAGYN SURGICAL 8850 M-89 Richland, MI 49083 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-12 |
| Decision Date | 2003-04-29 |
| Summary: | summary |