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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 K193350
Device Name Leadtek Fingertip Pulse Oximeter
Applicant
Leadtek Research Inc.
18F, No.166, Jian-Yi Rd., Zhonghe Dist
New Taipei City,  TW 23511
Applicant Contact K. S. Lu
Correspondent
Leadtek Research Inc.
18F, No.166, Jian-Yi Rd., Zhonghe Dist
New Taipei City,  TW 23511
Correspondent Contact Sharon Peng
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/03/2019
Decision Date 04/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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