The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System.
| Device ID | K101757 |
| 510k Number | K101757 |
| Device Name: | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
| Contact | Mary K Moore |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-23 |
| Decision Date | 2010-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105747 | K101757 | 000 |
| 00841517110390 | K101757 | 000 |
| 00841517108908 | K101757 | 000 |
| 00841517108939 | K101757 | 000 |
| 00841517108946 | K101757 | 000 |
| 00841517108953 | K101757 | 000 |
| 00841517108960 | K101757 | 000 |
| 00841517109561 | K101757 | 000 |
| 00841517109578 | K101757 | 000 |
| 00841517109608 | K101757 | 000 |
| 00841517109721 | K101757 | 000 |
| 00841517109769 | K101757 | 000 |
| 00841517105716 | K101757 | 000 |
| 00841517105730 | K101757 | 000 |
| 00841517110468 | K101757 | 000 |