FDA 510(k) Application Details - K202543

Device Classification Name Blood Pressure Cuff

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510(K) Number K202543
Device Name Blood Pressure Cuff
Applicant Volcano Corporation
3721 Valley Centre Drive, Ste 500
San Diego, CA 92130 US
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Contact Patrick Juarez
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/02/2020
Decision Date 09/28/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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