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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 K030230
Device Name AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
Applicant
Avita Corporation
3892 S. America W. Trl.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Avita Corporation
3892 S. America W. Trl.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/22/2003
Decision Date 05/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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