The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Edge Ultrasound System.
| Device ID | K113156 |
| 510k Number | K113156 |
| Device Name: | SONOSITE EDGE ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
| Contact | Scott Paulson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-26 |
| Decision Date | 2011-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105754 | K113156 | 000 |
| 00841517106447 | K113156 | 000 |
| 00841517107598 | K113156 | 000 |
| 00841517107628 | K113156 | 000 |
| 00841517108113 | K113156 | 000 |
| 00841517106829 | K113156 | 000 |
| 00841517109585 | K113156 | 000 |
| 00841517110369 | K113156 | 000 |
| 00841517110352 | K113156 | 000 |