SONOCALC


Device Classification Name

system, image processing, radiological

510(k) Number K030223
Device Name SONOCALC
Original Applicant
SONOMETRIC HEALTH, LLC
1373 e. skyline dr.
bountiful, 
UT 
84010

Original Contact helmut fritz
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 01/22/2003
Decision Date 02/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls