CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION


Device Classification Name

system, monitoring, perinatal

510(k) Number K051175
Device Name CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
Applicant
CIVENT COMMUNICATIONS LTD
meshek 58
ben nnatan
moshav hemed, 

IL

50295

Applicant Contact rudi lokits
Correspondent
CIVENT COMMUNICATIONS LTD
meshek 58
ben nnatan
moshav hemed, 

IL

50295

Correspodent Contact rudi lokits
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 05/06/2005
Decision Date 02/17/2006
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

Recalls CDRH Recalls