The following data is part of a premarket notification filed by Wipro Ge Healthcare Private, Ltd. with the FDA for Ge Vivid P3 Diagnostic Ultrasound Imaging System.
| Device ID | K102104 |
| 510k Number | K102104 |
| Device Name: | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | WIPRO GE HEALTHCARE PRIVATE, LTD. 9900 INNOVATION DRIVE Wwauwatosa, WI 53236 |
| Contact | Bryan Behn |
| Correspondent | Monica Morrison WIPRO GE HEALTHCARE PRIVATE, LTD. P.O.Box 7550 Madison, WI 53707 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-27 |
| Decision Date | 2010-10-01 |
| Summary: | summary |