The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Ge Vivid E9 Diagnostic Ultrasound Imaging System.
| Device ID | K131514 |
| 510k Number | K131514 |
| Device Name: | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE VINGMED ULTRASOUND AS 9900 W INNOVATION DR., RP-2138 Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE VINGMED ULTRASOUND AS 9900 W INNOVATION DR., RP-2138 Wauwatosa, WI 53226 |
| 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 | 2013-05-28 |
| Decision Date | 2013-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682121101 | K131514 | 000 |
| 00840682115681 | K131514 | 000 |
| 00840682112598 | K131514 | 000 |