The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite Sii Ultrasound System.
| Device ID | K183235 |
| 510k Number | K183235 |
| Device Name: | SonoSite SII Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 -3904 |
| Contact | Aditi Chaubal |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105792 | K183235 | 000 |
| 00841517108144 | K183235 | 000 |