510(k) K231478
K231478 is an FDA 510(k) premarket notification submitted by Wenzhou Yosun Medical Technology Co.,Ltd for the device "Digital Blood Pressure Monitor (Model: YB-800)". The FDA issued a decision of Substantially Equivalent on December 15, 2023. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Wenzhou Yosun Medical Technology Co.,Ltd has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2023
- Date Received
- May 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type