510(k) K220882
K220882 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Ultrasound And for the device "Vivid E80, Vivid E90, Vivid E95". The FDA issued a decision of Substantially Equivalent on Jul 22, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ge Medical Systems Ultrasound And has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2022
- Date Received
- Mar 25, 2022
- 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
- 510(k)