510(k) K061488
K061488 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments (Siui for the device "CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 30, 2006. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Shantou Institute Of Ultrasonic Instruments (Siui has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 2006
- Date Received
- May 31, 2006
- Clearance Type
- Special
- 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