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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 K220101
Device Name Pulse Oximeter
Applicant
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor And Rm. 410-412 4th Floor
# 2 Bldg. # 9 Shuangyuan Rd. Shijingshan
Beijing,  CN 100041
Applicant Contact Haiying Zhao
Correspondent
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor And Rm. 410-412 4th Floor
# 2 Bldg. # 9 Shuangyuan Rd. Shijingshan
Beijing,  CN 100041
Correspondent Contact Haiying Zhao
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/12/2022
Decision Date 03/08/2023
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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