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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 K180155
Device Name Arm Type Blood Pressure Monitor
Applicant
Avita Corporation
9f, #78, Sec. 1, Kwang-Fu Rd., San-Chung District
New Taipei City,  TW 24158
Applicant Contact Steven Jhou
Correspondent
Zhengcheng Consulting Company
#19, 335 Ln., Fu-Xi Rd., Shulin Dist., New Taipei City
New Taipei,  TW 238
Correspondent Contact Anita Chen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/19/2018
Decision Date 08/03/2018
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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