510(k) K083043
K083043 is an FDA 510(k) premarket notification submitted by Shenzhen Kingyield Technology Co., Ltd. for the device "KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201". The FDA issued a decision of Substantially Equivalent on Oct 27, 2008. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Kingyield Technology Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 2008
- Date Received
- Oct 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type
- 510(k)