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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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