NORAS MR-BI320-PA 1.5T


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K081118
Device Name NORAS MR-BI320-PA 1.5T
Applicant
NORAS MRI PRODUCTS GMBH
leibnitzstrasse 4
hoechberg, 

DE

97204

Applicant Contact martin hempel
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 04/21/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No