510(k) K173000
K173000 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) for the device "Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System". The FDA issued a decision of Substantially Equivalent on Dec 7, 2017. 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
- Dec 7, 2017
- Date Received
- Sep 27, 2017
- 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)