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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K233276
Device Name Reusable Blood Pressure Cuff
Applicant
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
You Yi Industrial Park, Songlin Town, Wujiang
Suzhou,  CN 215222
Applicant Contact Michael Ying
Correspondent
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
#789, Wu Fang Rd., Friendship Industrial Zone,
Song Ling Town, Wu Jiang
Suzhou,  CN 215222
Correspondent Contact Alex Wang
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received09/29/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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