SENTINELLA 102


Device Classification Name

camera, scintillation (gamma)

510(k) Number K110601
Device Name SENTINELLA 102
Applicant
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
camino de vera s/n
edificio 9b
valencia, 

ES

46022

Applicant Contact severine moine
Regulation Number 892.1100
Classification Product Code
IYX  
Date Received 03/02/2011
Decision Date 03/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No