510(k) K160853
K160853 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) for the device "Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System". The FDA issued a decision of Substantially Equivalent on Jun 27, 2016. 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 Co., Ltd. (Siui) has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 27, 2016
- Date Received
- Mar 28, 2016
- 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
- 510(k)