The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180plus Ultrasound System, Model L03073, L02245, L02464.
| Device ID | K033367 |
| 510k Number | K033367 |
| Device Name: | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
| Contact | Michael A Hoffman |
| 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 | 2003-10-21 |
| Decision Date | 2003-11-05 |
| Summary: | summary |