510(k) K032491
K032491 is an FDA 510(k) premarket notification submitted by Imagyn Medical Technologies, Inc. for the device "ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR". The FDA issued a decision of SESU on September 4, 2003. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Imagyn Medical Technologies, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- September 4, 2003
- Date Received
- August 12, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type