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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 K252448
Device Name AViTA Pulse Oximeter (SP61)
Applicant
Avita Corporation
9f, #78, Sec.1, Kwang Fu Rd., Sanchong Dist.
New Taipei City,  CN 24158
Applicant Contact Hsieh Rex
Correspondent
Avita Corporation
9f, #78, Sec.1, Kwang Fu Rd., Sanchong Dist.
New Taipei City,  CN 24158
Correspondent Contact Hsieh Rex
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/04/2025
Decision Date 02/27/2026
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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