FDA 510(k) Application Details - K251045

Device Classification Name Blood Pressure Cuff

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510(K) Number K251045
Device Name Blood Pressure Cuff
Applicant Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park, Tangtou, Shiyan,
Baoan District
Shenzhen CN
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Contact Huanyu Zeng
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 04/03/2025
Decision Date 07/15/2025
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 K251045


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