CAROTID COIL 5000004901

Coil, Magnetic Resonance, Specialty

SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD

The following data is part of a premarket notification filed by Shanghai Chenguang Medical Technologies Co, Ltd with the FDA for Carotid Coil 5000004901.

Pre-market Notification Details

Device IDK092962
510k NumberK092962
Device Name:CAROTID COIL 5000004901
ClassificationCoil, Magnetic Resonance, Specialty
Applicant SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD BLDG 8, LANE 1199, JIDI ROAD Shanghai,  CN 201107
ContactJie Huang
CorrespondentCasey Conry
UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville,  NY  11747
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-09-25
Decision Date2009-10-09
Summary:summary

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