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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, #166, Jian-Yi Rd., Zhonghe Dist
New Taipei City,  TW 23511
Applicant Contact K. S. Lu
Correspondent
Leadtek Research, Inc.
18f, #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
Predetermined Change
Control Plan Authorized		 No
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