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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 K242193
Device Name Arm Type Blood Pressure Monitor (BPM82)
Applicant
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., Sanchong Dist.
New Taipei,  TW 24158
Applicant Contact Maggie Chao
Correspondent
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., Sanchong Dist.
New Taipei,  TW 24158
Correspondent Contact Maggie Chao
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/26/2024
Decision Date 10/22/2024
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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