EUCLID (TM) TIER 1-GW ACCESS SYSTEM


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K111426
Device Name EUCLID (TM) TIER 1-GW ACCESS SYSTEM
Applicant
HOUSTON MEDICAL ROBOTICS
42 north chantsong circle
the woodlands, 
TX 
77382

Applicant Contact darla j elkin
Correspondent
HOUSTON MEDICAL ROBOTICS
42 north chantsong circle
the woodlands, 
TX 
77382

Correspodent Contact darla j elkin
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 05/23/2011
Decision Date 03/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No