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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 K242876
Device Name Pulse Oximeter ( PO2, PO2A, PO2B)
Applicant
Shenzhen Viatom Technology Co., Ltd.
501, Bldg. B, Ganghongji High-Tech Intelligent Industrial
Park, #1008 Songbai Rd. Xili St., Nanshan District
Shenzhen,  CN 518055
Applicant Contact Lynne Li
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/23/2024
Decision Date 02/28/2025
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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