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510(k) K171889

Reusable Blood Pressure Cuff by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2017
Date Received
June 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood Pressure Cuff
Device Class
Class II
Regulation Number
870.1120
Review Panel
CV
Submission Type

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

Other clearances by Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
  • K180389 — Venera 508 Deep Vein Thrombosis (DVT) Prevention System (June 29, 2018)

Other clearances for product code DXQ

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  • K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
  • K250765 — AViTA Arm Type Blood Pressure Monitor Cuff (September 3, 2025)
  • K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U168 (July 15, 2025)
  • K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff (October 31, 2024)
  • K240165 — Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer (March 20, 2024)
  • K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
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  • K231961 — NIBPCuff (August 30, 2023)