FDA 510(k) Application Details - K233276

Device Classification Name Blood Pressure Cuff

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510(K) Number K233276
Device Name Blood Pressure Cuff
Applicant Suzhou Minhua Medical Apparatus Supplies Co., LTD
You Yi Industrial Park, Songlin Town, Wujiang
Suzhou 215222 CN
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Contact Michael Ying
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/29/2023
Decision Date 12/21/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233276


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