8ch Flex Suite

Coil, Magnetic Resonance, Specialty

Shenzhen RF Tech Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Rf Tech Co., Ltd. with the FDA for 8ch Flex Suite.

Pre-market Notification Details

Device IDK200836
510k NumberK200836
Device Name:8ch Flex Suite
ClassificationCoil, Magnetic Resonance, Specialty
Applicant Shenzhen RF Tech Co., Ltd. 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen,  CN 518132
ContactGary Wang
CorrespondentGary Wang
Shenzhen RF Tech Co., Ltd. 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen,  CN 518132
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-07-22

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