The following data is part of a premarket notification filed by Fujifilm Sonosite,inc. with the FDA for X-porte Ultrasound System.
| Device ID | K133134 |
| 510k Number | K133134 |
| Device Name: | X-PORTE ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SONOSITE,INC. 21919 30th Dr SE Bothell, WA 98021 |
| Contact | Scott Paulson |
| 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 | 2013-10-01 |
| Decision Date | 2013-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517104740 | K133134 | 000 |
| 00841517104733 | K133134 | 000 |
| 00841517104436 | K133134 | 000 |
| 00841517104412 | K133134 | 000 |
| 00841517106423 | K133134 | 000 |
| 00841517106416 | K133134 | 000 |
| 00841517106409 | K133134 | 000 |
| 00841517106393 | K133134 | 000 |