510(k) K211532
K211532 is an FDA 510(k) premarket notification submitted by Yibin Junxin Electronics Technology Co., Ltd. for the device "Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33". The FDA issued a decision of Substantially Equivalent on Jan 19, 2022. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Yibin Junxin Electronics Technology Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 19, 2022
- Date Received
- May 18, 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
- 510(k)