TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER


Device Classification Name

monitor, ultrasonic, fetal

510(k) Number K112529
Device Name TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 west 20 st
hialeah, 
FL 
33010

Applicant Contact jorge millan
Correspondent
ADVANCED INSTRUMENTATIONS, INC.
601 west 20 st
hialeah, 
FL 
33010

Correspodent Contact jorge millan
Regulation Number 884.2660
Classification Product Code
KNG  
Date Received 08/31/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No