510(k) K033367
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 by
Sonosite,Inc.
— Product Code IYN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2003
- Date Received
- October 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type