Ecom CV4 Endotracheal Cardiac Output Monitor
FDA 510(k) K032491 · Imagyn Medical Technologies, Inc.
510(k) numberK032491
Submission
- Device name
- Ecom CV4 Endotracheal Cardiac Output Monitor
- Applicant
- Imagyn Medical Technologies, Inc.
Irvine, CA, US - Received
- August 12, 2003
- Decision date
- September 4, 2003
- Decision
- Unknown (SESU)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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Questions and answers
When was Ecom CV4 Endotracheal Cardiac Output Monitor cleared by the FDA?
Ecom CV4 Endotracheal Cardiac Output Monitor (K032491) received a 510(k) decision of Unknown on September 4, 2003, 23 days after the submission was received.
What is the product code of K032491?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.