510(k) K003479
K003479 is an FDA 510(k) premarket notification submitted by U-Systems, Inc. for the device "U-SYSTEMS ULTRASOUND SYSTEM USI-2000". The FDA issued a decision of Substantially Equivalent on January 18, 2001. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. U-Systems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2001
- Date Received
- November 9, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type