FM-1000 PLUS FETAL MONITOR


Device Classification Name

system, monitoring, perinatal

510(k) Number K112187
Device Name FM-1000 PLUS FETAL MONITOR
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 w 20 st
hialeah, 
FL 
33010

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

Correspodent Contact jorge millan
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 07/29/2011
Decision Date 09/21/2011
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