The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Nanomaxx Series Ultrasound System.
| Device ID | K102390 |
| 510k Number | K102390 |
| Device Name: | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
| Contact | Jessica R Stenberg |
| 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 |
| Subsequent Product Code | LMD |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-23 |
| Decision Date | 2010-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105594 | K102390 | 000 |
| 00841517100865 | K102390 | 000 |
| 00841517100858 | K102390 | 000 |
| 00841517100841 | K102390 | 000 |
| 00841517100834 | K102390 | 000 |
| 00841517100827 | K102390 | 000 |
| 00841517100810 | K102390 | 000 |
| 00841517100803 | K102390 | 000 |
| 00841517100797 | K102390 | 000 |
| 00841517100780 | K102390 | 000 |
| 00841517100773 | K102390 | 000 |
| 00841517100063 | K102390 | 000 |
| 00841517105778 | K102390 | 000 |
| 00841517100902 | K102390 | 000 |
| 00841517100919 | K102390 | 000 |
| 00841517101220 | K102390 | 000 |
| 00841517104078 | K102390 | 000 |
| 00841517103149 | K102390 | 000 |
| 00841517102166 | K102390 | 000 |
| 00841517102128 | K102390 | 000 |
| 00841517102050 | K102390 | 000 |
| 00841517101749 | K102390 | 000 |
| 00841517101367 | K102390 | 000 |
| 00841517101350 | K102390 | 000 |
| 00841517101343 | K102390 | 000 |
| 00841517101336 | K102390 | 000 |
| 00841517101329 | K102390 | 000 |
| 00841517101237 | K102390 | 000 |
| 00841517106096 | K102390 | 000 |