SIMPLEABI


Device Classification Name

monitor, ultrasonic, nonfetal

510(k) Number K110628
Device Name SIMPLEABI
Applicant
NEWMAN MEDICAL
5350 vivian street
unit c
arvada, 
CO 
80002

Applicant Contact spencer newman
Regulation Number 892.1540
Classification Product Code
JAF  
Subsequent Product Code
ITX  
Date Received 03/03/2011
Decision Date 05/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No