510(k) K230084
K230084 is an FDA 510(k) premarket notification submitted by Samsung Medison Co., Ltd. for the device "HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on April 21, 2023. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Samsung Medison Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2023
- Date Received
- January 11, 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