510(k) K210768
K210768 is an FDA 510(k) premarket notification submitted by Andon Health Co, Ltd. for the device "Wrist Blood Pressure Monitor, Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on July 30, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Andon Health Co, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2021
- Date Received
- March 15, 2021
- Clearance Type
- Abbreviated
- 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