CAROTID COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K112002
Device Name CAROTID COIL
Applicant
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
bldg 8, lane 1199, jidi road
shanghai, 

CN

201107

Applicant Contact meijuan chen
Correspondent
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
bldg 8, lane 1199, jidi road
shanghai, 

CN

201107

Correspodent Contact meijuan chen
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 07/13/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No