510(k) K172196
K172196 is an FDA 510(k) premarket notification submitted by Ecom Medical, Inc. for the device "ECOM Cardiac Output Monitoring System". The FDA issued a decision of Substantially Equivalent on September 19, 2017. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2017
- Date Received
- July 21, 2017
- Clearance Type
- Traditional
- 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