TEMPOROMANIBULAR COIL 15


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K110373
Device Name TEMPOROMANIBULAR COIL 15
Applicant
ESAOTE S.P.A.
via siffredi 58
genova, 

IT

16153

Applicant Contact donatella ragghianti
Correspondent
ESAOTE S.P.A.
via siffredi 58
genova, 

IT

16153

Correspodent Contact donatella ragghianti
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 02/08/2011
Decision Date 04/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No