MONICA IF24


Device Classification Name

uterine electromyographic monitor

510(k) Number K112163
Device Name MONICA IF24
Applicant
MONICA HEALTHCARE
pennyfoot street
nottingham, 

GB

ng1 1gf

Applicant Contact ian how
Regulation Number 884.2720
Classification Product Code
OSP  
Subsequent Product Code
HGM  
Date Received 07/27/2011
Decision Date 08/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No