510(k) K193518
K193518 is an FDA 510(k) premarket notification submitted by EchoNous, Inc. for the device "KOSMOS". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. EchoNous, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2020
- Date Received
- December 19, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type