BIRTHTRACK


Device Classification Name

system, monitoring, for progress of labor

510(k) Number K080672
Device Name BIRTHTRACK
Applicant
BARNEV, LTD.
20 hata’as st.
kfar saba, 

IL

44425

Applicant Contact ahava stein
Correspondent
BARNEV, LTD.
20 hata’as st.
kfar saba, 

IL

44425

Correspodent Contact ahava stein
Regulation Number 884.2800
Classification Product Code
NPB  
Date Received 03/10/2008
Decision Date 07/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No