The following data is part of a premarket notification filed by Imagyn Medical Technologies, Inc. with the FDA for Ecom Cv4 Endotracheal Cardiac Output Monitor.
| Device ID | K032491 |
| 510k Number | K032491 |
| Device Name: | ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR |
| Classification | Plethysmograph, Impedance |
| Applicant | IMAGYN MEDICAL TECHNOLOGIES, INC. 1 PARK PLAZA, SUITE 1100 Irvine, CA 92614 |
| Contact | Julie Powell |
| Correspondent | Julie Powell IMAGYN MEDICAL TECHNOLOGIES, INC. 1 PARK PLAZA, SUITE 1100 Irvine, CA 92614 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-12 |
| Decision Date | 2003-09-04 |
| Summary: | summary |