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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 K172616
Device Name Pulse Oximeter
Applicant
Beijing Safe Heart Technology , Ltd.
Rm. 101, Unit 6, Bldg. #6
#88 Kechuang 6th St.
Beijing Economic-Technological Developme,  CN 101111
Applicant Contact Xiaoming Yang
Correspondent
Beijing Safe Heart Technology , Ltd.
Rm. 101, Unit 6, Bldg. #6
#88 Kechuang 6th St.
Beijing Economic-Technological Developme,  CN 101111
Correspondent Contact Xiaoming Yang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/31/2017
Decision Date 07/27/2018
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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