NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)— 510(k) K253089
Substantially EquivalentShenzhen Best Electronics Co., Ltd.
FDA 510(k) clearance K253089 for NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722), Substantially Equivalent on 2026-02-13. Applicant: Shenzhen Best Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Best Electronics Co., Ltd.
- Product code
- Code DXQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1120
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DXQ
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- K250765 — AViTA Arm Type Blood Pressure Monitor Cuff
More clearances from Shenzhen Best Electronics Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.