FDA 510(k) Application Details - K101972

Device Classification Name Blood Pressure Cuff

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510(K) Number K101972
Device Name Blood Pressure Cuff
Applicant SOLARIS MEDICAL TECHNOLOGY, INC.
400 OYSTER POINT BLVD.
SUITE 534
SOUTH SAN FRANCISCO, CA 94080 US
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Contact RACHEL CHENG
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/13/2010
Decision Date 07/22/2010
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 Y
Expedited Review

FDA Source Information for K101972


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