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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 K210032
Device Name Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
Applicant
Leadtek Research Inc.
18F, No. 166, Jian-Yi Rd., Chung Ho Dist.
New Taipei City,  TW 23511
Applicant Contact Kun-Shan Lu
Correspondent
Leadtek Research Inc.
18F, No. 166, Jian-Yi Rd., Chung Ho Dist.
New Taipei City,  TW 23511
Correspondent Contact Sharon Peng
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/05/2021
Decision Date 09/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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