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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K102624
Device Name AVITA WRIST TYPE BLOOD PRESSURE MONITOR
Applicant
Avita Corporation
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Avita Corporation
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/13/2010
Decision Date 12/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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