Clearance Summary
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR received FDA 510(k) clearance under submission number K032491, sponsored by Imagyn Medical Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-09-04.
- Submission: K032491
- Applicant / Sponsor: Imagyn Medical Technologies, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2003-09-04
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.