The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Micromaxx Diagnostic Ultrasound System (c3 Series).
| Device ID | K053069 |
| 510k Number | K053069 |
| Device Name: | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) |
| Classification | System, Imaging, Pulsed Doppler, 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 | 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 | 2005-11-01 |
| Decision Date | 2005-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105129 | K053069 | 000 |
| 00841517102845 | K053069 | 000 |
| 00841517102838 | K053069 | 000 |
| 00841517102586 | K053069 | 000 |
| 00841517102579 | K053069 | 000 |
| 00841517102562 | K053069 | 000 |
| 00841517102555 | K053069 | 000 |
| 00841517102296 | K053069 | 000 |
| 00841517101664 | K053069 | 000 |
| 00841517101275 | K053069 | 000 |
| 00841517101268 | K053069 | 000 |
| 00841517101190 | K053069 | 000 |
| 00841517101183 | K053069 | 000 |
| 00841517100643 | K053069 | 000 |
| 00841517100636 | K053069 | 000 |
| 00841517105761 | K053069 | 000 |
| 00841517102968 | K053069 | 000 |
| 00841517103255 | K053069 | 000 |
| 00841517104795 | K053069 | 000 |
| 00841517104016 | K053069 | 000 |
| 00841517104009 | K053069 | 000 |
| 00841517103989 | K053069 | 000 |
| 00841517103736 | K053069 | 000 |
| 00841517103729 | K053069 | 000 |
| 00841517103699 | K053069 | 000 |
| 00841517103552 | K053069 | 000 |
| 00841517103439 | K053069 | 000 |
| 00841517103422 | K053069 | 000 |
| 00841517103361 | K053069 | 000 |
| 00841517103309 | K053069 | 000 |
| 00841517103286 | K053069 | 000 |
| 00841517103279 | K053069 | 000 |
| 00841517103262 | K053069 | 000 |
| 00841517106430 | K053069 | 000 |