PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K081340
Device Name PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
Applicant
SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD
340 shady grove road
flintville, 
TN 
37335

Applicant Contact charles mack
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 05/13/2008
Decision Date 06/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No