510(k) K233439
K233439 is an FDA 510(k) premarket notification submitted by Qingdao Hisense Medical Equipment Co., Ltd. for the device "HD60 Series Ultrasound Diagnostic System". The FDA issued a decision of Substantially Equivalent on February 21, 2024. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Qingdao Hisense Medical Equipment Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2024
- Date Received
- October 16, 2023
- 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