The following data is part of a premarket notification filed by Fujifilm Sonosite,inc. with the FDA for Sonosite Edge Ultrasound System.
| Device ID | K133454 |
| 510k Number | K133454 |
| Device Name: | SONOSITE EDGE ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SONOSITE,INC. 21919 30th Dr SE Bothell, WA 98021 |
| Contact | Patricia Liau |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2013-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517103897 | K133454 | 000 |
| 00841517101763 | K133454 | 000 |
| 00841517101725 | K133454 | 000 |
| 00841517101718 | K133454 | 000 |
| 00841517101381 | K133454 | 000 |
| 00841517101374 | K133454 | 000 |
| 00841517100247 | K133454 | 000 |
| 00841517100230 | K133454 | 000 |
| 00841517100117 | K133454 | 000 |
| 00841517100025 | K133454 | 000 |
| 00841517105723 | K133454 | 000 |
| 00841517105785 | K133454 | 000 |
| 00841517105457 | K133454 | 000 |
| 00841517105440 | K133454 | 000 |
| 00841517105433 | K133454 | 000 |
| 00841517105426 | K133454 | 000 |
| 00841517101770 | K133454 | 000 |
| 00841517102098 | K133454 | 000 |
| 00841517103217 | K133454 | 000 |
| 00841517103200 | K133454 | 000 |
| 00841517103194 | K133454 | 000 |
| 00841517103187 | K133454 | 000 |
| 00841517103170 | K133454 | 000 |
| 00841517103163 | K133454 | 000 |
| 00841517102791 | K133454 | 000 |
| 00841517102784 | K133454 | 000 |
| 00841517102777 | K133454 | 000 |
| 00841517102678 | K133454 | 000 |
| 00841517102661 | K133454 | 000 |
| 00841517102654 | K133454 | 000 |
| 00841517102647 | K133454 | 000 |
| 00841517102517 | K133454 | 000 |
| 00841517102500 | K133454 | 000 |
| 00841517107345 | K133454 | 000 |