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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 K211632
Device Name Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
Applicant
Shenzhen Narig Bio-Medical Technology Co., Ltd.
1106 Room, East Tower, Digital Culture Industry Base
No.10128 Shennan Road, Nanshan District
Shenzhen,  CN 518052
Applicant Contact Fei Han
Correspondent
Shenzhen Narig Bio-Medical Technology Co., Ltd.
1106 Room, East Tower, Digital Culture Industry Base
No.10128 Shennan Road, Nanshan District
Shenzhen,  CN 518052
Correspondent Contact Fei Han
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/27/2021
Decision Date 01/14/2022
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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