510(k) K210563
K210563 is an FDA 510(k) premarket notification submitted by Alicn Medical Shenzhen, Inc. for the device "Arm Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on October 15, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Alicn Medical Shenzhen, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2021
- Date Received
- February 25, 2021
- 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