The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Maxx Series Diagnostic Ultrasound System.
| Device ID | K071134 |
| 510k Number | K071134 |
| Device Name: | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
| Contact | Daina L Graham |
| 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 | 2007-04-23 |
| Decision Date | 2007-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517104788 | K071134 | 000 |
| 00841517106010 | K071134 | 000 |
| 00841517106003 | K071134 | 000 |
| 00841517106881 | K071134 | 000 |
| 00841517106898 | K071134 | 000 |
| 00841517107833 | K071134 | 000 |
| 00841517107895 | K071134 | 000 |
| 00841517108380 | K071134 | 000 |
| 00841517106843 | K071134 | 000 |
| 00841517106812 | K071134 | 000 |
| 00841517106607 | K071134 | 000 |
| 00841517106638 | K071134 | 000 |
| 00841517104771 | K071134 | 000 |
| 00841517104764 | K071134 | 000 |
| 00841517104757 | K071134 | 000 |
| 00841517104665 | K071134 | 000 |
| 00841517104559 | K071134 | 000 |
| 00841517104542 | K071134 | 000 |
| 00841517104498 | K071134 | 000 |
| 00841517105099 | K071134 | 000 |
| 00841517106645 | K071134 | 000 |
| 00841517108557 | K071134 | 000 |