The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite Px Ultrasound System.
| Device ID | K213763 |
| 510k Number | K213763 |
| Device Name: | Sonosite PX Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM Sonosite, Inc. 21919 30th Drive SE Bothell, WA 98021 -3904 |
| Contact | Anoush Frankian |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OIJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-01 |
| Decision Date | 2021-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517107543 | K213763 | 000 |
| 00841517110093 | K213763 | 000 |
| 00841517109158 | K213763 | 000 |
| 00841517109905 | K213763 | 000 |
| 00841517109219 | K213763 | 000 |
| 00841517109226 | K213763 | 000 |
| 00841517109233 | K213763 | 000 |
| 00841517108175 | K213763 | 000 |
| 00841517108472 | K213763 | 000 |
| 00841517108489 | K213763 | 000 |
| 00841517108496 | K213763 | 000 |
| 00841517107802 | K213763 | 000 |
| 00841517107796 | K213763 | 000 |
| 00841517107697 | K213763 | 000 |
| 00841517107659 | K213763 | 000 |
| 00841517107666 | K213763 | 000 |
| 00841517107574 | K213763 | 000 |
| 00841517109400 | K213763 | 000 |