MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K081322
Device Name MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
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 05/12/2008
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