The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Fujifilm Sonosite Vevo Md Imaging System.
| Device ID | K190476 |
| 510k Number | K190476 |
| Device Name: | FUJIFILM Sonosite Vevo MD Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 -3904 |
| Contact | Anoush Frankian |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105471 | K190476 | 000 |
| 00841517105464 | K190476 | 000 |