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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, No. 6-1, Sec.2, Shengyi Rd.
Zhubei,  TW 30261
Applicant Contact JC Chen
Correspondent
Taiwan Biophotonic Corporation
4F-1, No. 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
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