UBM PLUS


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K103471
Device Name UBM PLUS
Applicant
ACCUTOME, INC.
3222 phoenixville pike
malvern, 
PA 
19355

Applicant Contact brian t.s. barrett
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Code
ITX  
Date Received 11/24/2010
Decision Date 03/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No