SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS

Blood Pressure Cuff

SOLARIS MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Solaris Medical Technology, Inc. with the FDA for Solaris Reusable And Disposable Blood Pressure Cuffs.

Pre-market Notification Details

Device IDK101972
510k NumberK101972
Device Name:SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS
ClassificationBlood Pressure Cuff
Applicant SOLARIS MEDICAL TECHNOLOGY, INC. 400 OYSTER POINT BLVD. SUITE 534 South San Francisco,  CA  94080
ContactRachel Cheng
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-07-13
Decision Date2010-07-22

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