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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 K183556
Device Name oCare Wrist Pulse Oximeter
Applicant
Taiwan Biophotonic Corporation
4f-1, # 6-1, Sec.2, Shengyi Rd.
Zhubei,  TW 30261
Applicant Contact JC Chen
Correspondent
Taiwan Biophotonic Corporation
4f-1, # 6-1, Sec.2, Shengyi Rd.
Zhubei,  TW 30261
Correspondent Contact JC Chen
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/20/2018
Decision Date 02/15/2019
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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