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FDA 510(k) Application Details - K101972
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1120
More FDA Info for this Regulation Number
Classification Product Code
DXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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