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510(k) K222420

Disposable Blood Pressure Cuff by Wenzhou Xikang Medical Instruments Co., Ltd. — Product Code DXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2022
Date Received
August 11, 2022
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 Wenzhou Xikang Medical Instruments Co., Ltd.

  • K212416 — WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressur (May 18, 2022)

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