FM-9000 PLUS FETAL AND MATERNAL MONITOR


Device Classification Name

system, monitoring, perinatal

510(k) Number K112317
Device Name FM-9000 PLUS FETAL AND MATERNAL MONITOR
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 884.2740
Classification Product Code
HGM  
Date Received 08/11/2011
Decision Date 12/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No