The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Titan High Resolution Ultrasound System.
Device ID | K030949 |
510k Number | K030949 |
Device Name: | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SONOSITE,INC. 21919 30TH DRIVE SE. Bothell, WA 98021 -3904 |
Contact | Michael Hoffman |
Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-03-26 |
Decision Date | 2003-04-07 |
Summary: | summary |