The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Titan High Resolution Ultrasound System And Sonosite Ultrasound System.
| Device ID | K043452 |
| 510k Number | K043452 |
| Device Name: | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM |
| 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 | 2004-12-15 |
| Decision Date | 2004-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517102173 | K043452 | 000 |
| 00841517102135 | K043452 | 000 |
| 00841517102067 | K043452 | 000 |
| 00841517101756 | K043452 | 000 |
| 00841517101602 | K043452 | 000 |
| 00841517100070 | K043452 | 000 |