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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K250765
Device Name AViTA Arm Type Blood Pressure Monitor Cuff
Applicant
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., Sanchong Dist.,
New Taipei City,  TW 24158
Applicant Contact Rex Hsieh
Correspondent
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., Sanchong Dist.,
New Taipei City,  TW 24158
Correspondent Contact Rex Hsieh
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/13/2025
Decision Date 09/03/2025
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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