PD-100 SERIES ULTRASONIC POCKET DOPPLER


Device Classification Name

monitor, ultrasonic, fetal

510(k) Number K111934
Device Name PD-100 SERIES ULTRASONIC POCKET 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  
Subsequent Product Code
HEP  
Date Received 07/08/2011
Decision Date 09/22/2011
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