510(k) K170085
K170085 is an FDA 510(k) premarket notification submitted by Healcerion Co., Ltd. for the device "SONON Ultrasound Imaging System, Model: 300L". The FDA issued a decision of Substantially Equivalent on Oct 12, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Healcerion Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 2017
- Date Received
- Jan 10, 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)