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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K223399
Device Name AViTA Pulse Oximeter
Applicant
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., San-Chung District
New Taipei City,  TW 24158
Applicant Contact Joanna Lin
Correspondent
Avita Corporation
9f, #78, Sec.1, Kwang-Fu Rd., San-Chung District
New Taipei City,  TW 24158
Correspondent Contact Joanna Lin
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/09/2022
Decision Date 05/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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