510(k) K210318
K210318 is an FDA 510(k) premarket notification submitted by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (Siui) for the device "Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System". The FDA issued a decision of Substantially Equivalent on Aug 18, 2021. 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
- Aug 18, 2021
- Date Received
- Feb 3, 2021
- 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)