Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

Oximeter

Shenzhen Narig Bio-Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Narig Bio-medical Technology Co., Ltd. with the FDA for Pulse Oximeter (fro-200, Fro-201, Fro-202, Fro-203, Fro-204, Fro-100, Fro-101, Fro-102, Fro-103, Fro-104).

Pre-market Notification Details

Device IDK211632
510k NumberK211632
Device Name:Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
ClassificationOximeter
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
ContactFei Han
CorrespondentFei Han
Shenzhen Narig Bio-Medical Technology Co., Ltd. 1106 Room, East Tower, Digital Culture Industry Base No.10128 Shennan Road, Nanshan District Shenzhen,  CN 518052
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-27
Decision Date2022-01-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06973927160185 K211632 000
00850000967410 K211632 000
00850000967403 K211632 000

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