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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 K033397
Device Name AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY
Applicant
Avita Corporation
9f, # 78, Sec. 1,
Kwang-Fu Rd.
San-Chung,  TW 241
Applicant Contact GEO LIN
Correspondent
Avita Corporation
9f, # 78, Sec. 1,
Kwang-Fu Rd.
San-Chung,  TW 241
Correspondent Contact GEO LIN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/24/2003
Decision Date 04/09/2004
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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