510(k) K180535
K180535 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Voluson P6 and Voluson P8". The FDA issued a decision of Substantially Equivalent on Mar 29, 2018. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. GE Healthcare has 168 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 29, 2018
- Date Received
- Feb 28, 2018
- Clearance Type
- Special
- 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)