The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System.
| Device ID | K150087 |
| 510k Number | K150087 |
| Device Name: | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE VINGMED ULTRASOUND AS Horten, NO 3191 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Healthcare 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-15 |
| Decision Date | 2015-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115728 | K150087 | 000 |
| 00840682115636 | K150087 | 000 |
| 00840682107075 | K150087 | 000 |
| 00840682102735 | K150087 | 000 |
| 00840682102698 | K150087 | 000 |