510(k) K102104
K102104 is an FDA 510(k) premarket notification submitted by Wipro GE Healthcare Private, Ltd. for the device "GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 2010. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Wipro GE Healthcare Private, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2010
- Date Received
- July 27, 2010
- 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