510(k) K261136
K261136 is an FDA 510(k) premarket notification submitted by Guangzhou Daxin Health Technology Co., Ltd. for the device "Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)". The FDA issued a decision of Substantially Equivalent on Jul 23, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Guangzhou Daxin Health Technology Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2026
- Date Received
- Apr 7, 2026
- 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)