Reusable NIBP Cuff— 510(k) K191253
Substantially EquivalentShenzhen Changke Connect Electronics Co., Ltd.
FDA 510(k) clearance K191253 for Reusable NIBP Cuff, Substantially Equivalent on 2019-09-17. Applicant: Shenzhen Changke Connect Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Changke Connect 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
- Longgang District, Shenzhen, CN
Recent devices under product code DXQ
view all- K254287 — Medline Reusable Blood Pressure Cuff
- K260747 — YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff
- K253089 — 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)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
More clearances from Shenzhen Changke Connect Electronics Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.