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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, NO. 78, SEC. 1,
KWANG-FU RD.
san-chung, taipei county,  TW 241
Applicant Contact geo lin
Correspondent
AVITA CORPORATION
9F, NO. 78, SEC. 1,
KWANG-FU RD.
san-chung, taipei county,  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
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